PROCHEM CHEMISTRY ANALYZER

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

PRISMA SYSTEMS

The following data is part of a premarket notification filed by Prisma Systems with the FDA for Prochem Chemistry Analyzer.

Pre-market Notification Details

Device IDK944028
510k NumberK944028
Device Name:PROCHEM CHEMISTRY ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome,  NY  13440
ContactLarry Beasley
CorrespondentLarry Beasley
PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome,  NY  13440
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-17
Decision Date1994-11-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.