CK REAGENT

Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

CAROLINA LIQUID CHEMISTRIES CORP.

The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corp. with the FDA for Ck Reagent.

Pre-market Notification Details

Device IDK971396
510k NumberK971396
Device Name:CK REAGENT
ClassificationNad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Applicant CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea,  CA  92821
ContactCynthia Shugart
CorrespondentCynthia Shugart
CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 Brea,  CA  92821
Product CodeCGS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-15
Decision Date1997-05-29

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