CONJUGATED BILE ACIDS RIA KIT

Radioimmunoassay, Cholyglycine, Bile Acids

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Conjugated Bile Acids Ria Kit.

Pre-market Notification Details

Device IDK781337
510k NumberK781337
Device Name:CONJUGATED BILE ACIDS RIA KIT
ClassificationRadioimmunoassay, Cholyglycine, Bile Acids
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington,  DC  20006
Product CodeKWW  
CFR Regulation Number862.1177 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-08-03
Decision Date1978-08-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817830022290 K781337 000

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