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510(k) Data Aggregation
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?
Product Code :
GHM
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
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?
Product Code :
GHM
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
K960947Device Name
SAS SICKLE CELL TEST
Manufacturer
SA SCIENTIFIC, INC.
Date Cleared
1996-07-01
(115 days)
Product Code
GHM
Regulation Number
864.7825Why did this record match?
Product Code :
GHM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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