CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

Radioimmunoassay, Cholyglycine, Bile Acids

CATACHEM, INC.

The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Catachem, Inc., Bile Acids Reagents And/or Bile Acids Test Kit.

Pre-market Notification Details

Device IDK062503
510k NumberK062503
Device Name:CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
ClassificationRadioimmunoassay, Cholyglycine, Bile Acids
Applicant CATACHEM, INC. 955 CONNECTICUT AVENUE SUITE 4106 Bridgeport,  CT  06607
ContactLuis P Leon
CorrespondentLuis P Leon
CATACHEM, INC. 955 CONNECTICUT AVENUE SUITE 4106 Bridgeport,  CT  06607
Product CodeKWW  
Subsequent Product CodeJIS
Subsequent Product CodeJJX
CFR Regulation Number862.1177 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-25
Decision Date2007-01-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00853618007011 K062503 000

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