PERSONALLAB AUTOMATED MICROPLATE ANALYZER

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

BIOCHEM IMMUNOSYSTEMS (U.S.), INC.

The following data is part of a premarket notification filed by Biochem Immunosystems (u.s.), Inc. with the FDA for Personallab Automated Microplate Analyzer.

Pre-market Notification Details

Device IDK971761
510k NumberK971761
Device Name:PERSONALLAB AUTOMATED MICROPLATE ANALYZER
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown,  PA  18103 -9562
ContactJames Safranko
CorrespondentJames Safranko
BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown,  PA  18103 -9562
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-12
Decision Date1997-07-22
Summary:summary

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