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Found 20 results
510(k) Data Aggregation
K Number
K042587Device Name
RETIC-CHEX FOR CELL-DYN
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2004-10-19
(27 days)
Product Code
JPK
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Retic-Chex for Cell-Dyn is an assayed control for evaluating the accuracy and precision of automated, semi-automated and manual methods of reticulocyte counting.
Device Description
Retic-Chex for Cell-Dyn is a suspension of stabilized human red blood cells and simulated human reticulocytes packaged in plastic vials containing 1.0ml volumes. The device consists of two levels of reticulocyte percentage range. Control I reticulocyte percent range will be 1.5 - 2.0. Control II reticulocyte percent range will be 3.9 - 5.8. Closures are injection molded polypropylene screw-top caps. The vials are packaged in vacuum molded clam-shell box.
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K Number
K040107Device Name
CYTO-CHEX BCT
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2004-07-27
(189 days)
Product Code
JKA
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.
Device Description
Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 57ul of sterile K,EDTA anti-coagulant and WBC preservative. It is manufactured with a vacuum to draw 5ml of blood by venipuncture.
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K Number
K040025Device Name
A1C-CELLULAR
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2004-03-02
(55 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A1c-Chex is a bi-level whole blood based, assayed control for monitoring performance of analysis procedures for HbA1c.
Device Description
A1c-Chex is bi-level, whole blood based, assayed control for monitoring performance of tastal A IC-Chex is blevel, whole blood, acouryed of he same as a patient specimen and tested procedures for ribATC. ATT offex brith the instrument, kit or reagent being used. A1c-Chex following the instructions included with the including in oversion of analysis procedures, including lysing of the RBC.
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K Number
K023656Device Name
SICKLE-CHEX SOLUBILITY KIT
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2002-12-30
(61 days)
Product Code
GHM
Regulation Number
864.7825Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
Device Description
Sickle-Chex Solubility Kit consists of:
- Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin.
- Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite.
The testing principles of the kit is based on NCCLS, H10-F.
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K Number
K021922Device Name
MODIFICATION TO PARA 5X
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2002-06-25
(14 days)
Product Code
JPK
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Para 5X is intended for use as a multi-parameter quality control material for ABX Pentra 60 C+ and Beckman Coulter™ AcT™ hematology analyzers. It includes assay values for CBC/Diff parameters.
Device Description
Para® 5X is a tri-level multi-parameter hematology control consisting of stabilized human red blood cells, human white blood cells and simulated platelets. The product is packaged in glass vials containing 3 ml. The closures are polypropylene screw caps with pierceable liners.
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K Number
K020469Device Name
CAL-CHEX CD PLUS
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2002-04-04
(51 days)
Product Code
KRX, KRY, KRZ, KSA
Regulation Number
864.8150Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cal-Chex CD Plus is intended to be used as a calibrator for the calibration of WBC, RBC, Hgb, MCV, PLT and MPV (MPV on CD4000 only) on the Abbott Cell-Dyn 3200 and 4000 hematology instruments.
Device Description
Cal-Chex CD Plus is a suspension of stabilized human red blood cells, human white blood cells, and human platelets packaged in glass vials containing 3.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in a PVC clamshell.
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K Number
K013316Device Name
SICKLE-CHEX
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2001-11-06
(33 days)
Product Code
GHM
Regulation Number
864.7825Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
Device Description
Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
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K Number
K011410Device Name
PARA 5X
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2001-06-26
(49 days)
Product Code
JPK
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001443Device Name
SUGAR CHEX ONE
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2000-06-29
(52 days)
Product Code
JJX
Regulation Number
862.1660Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000945Device Name
PARA 12 PLUS RETICS
Manufacturer
STRECK LABORATORIES, INC.
Date Cleared
2000-04-18
(26 days)
Product Code
GLQ
Regulation Number
864.8625Why did this record match?
Applicant Name (Manufacturer) :
STRECK LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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