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Found 6 results
510(k) Data Aggregation
K Number
K973109Device Name
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
Manufacturer
SYNERMED, INC.
Date Cleared
1997-09-25
(37 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Device Description
Not Found
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K Number
K972716Device Name
SYNERMED TOTAL BILIRUBIN REAGENT KIT
Manufacturer
SYNERMED, INC.
Date Cleared
1997-08-07
(17 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.
Elevated serum biliruhin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).
Device Description
Total Bilirubin Reagent Kit
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K Number
K971491Device Name
SYNERMED IR 200 CHEMISTRY ANALYZER
Manufacturer
SYNERMED, INC.
Date Cleared
1997-06-26
(63 days)
Product Code
JJF
Regulation Number
862.2170Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synermed® IR200™ analyzer is intended for in vitro diagnostic use as a multiparameter biochemistry instrument that sequentially quantitates levels of constituents in serum, plasma or urine. Testing is selective, i.e, only selected tests or profiles or automatic repeats of selected tests are performed on each sample.
The Synermed IR200 analyzer is specifically designed to perform tests with Synermed reagents or reagent applications recommended by Synermed. Consequently, no representation as to the general utility of the Synermed IR200 with other than Synermed reagents or approved applications is made and none should be inferred.
Device Description
Not Found
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K Number
K962479Device Name
SYNERMED ISE REAGENTS
Manufacturer
SYNERMED, INC.
Date Cleared
1997-03-03
(250 days)
Product Code
CGZ, CEM, JGS
Regulation Number
862.1170Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K963939Device Name
SYNERMED DIRECT BILIRUBIN REAGENT KIT
Manufacturer
SYNERMED, INC.
Date Cleared
1996-12-18
(78 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960793Device Name
SYNERMED ENZYMATIC CO2 REAGENT KIT
Manufacturer
SYNERMED, INC.
Date Cleared
1996-03-11
(13 days)
Product Code
KHS
Regulation Number
862.1160Why did this record match?
Applicant Name (Manufacturer) :
SYNERMED, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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