BILIRUBIN (DIRECT) QVET

Diazo Colorimetry, Bilirubin

PRISMA SYSTEMS

The following data is part of a premarket notification filed by Prisma Systems with the FDA for Bilirubin (direct) Qvet.

Pre-market Notification Details

Device IDK942949
510k NumberK942949
Device Name:BILIRUBIN (DIRECT) QVET
ClassificationDiazo Colorimetry, Bilirubin
Applicant PRISMA SYSTEMS 1721 BLACK RIVER BLVD. SUITE 200 Rome,  NY  13440
ContactLarry J Beasley
CorrespondentLarry J Beasley
PRISMA SYSTEMS 1721 BLACK RIVER BLVD. SUITE 200 Rome,  NY  13440
Product CodeCIG  
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-23
Decision Date1994-11-22

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