OPUS MAGNUM ANALYZER

Fluorometer, For Clinical Use

PB DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Magnum Analyzer.

Pre-market Notification Details

Device IDK926131
510k NumberK926131
Device Name:OPUS MAGNUM ANALYZER
ClassificationFluorometer, For Clinical Use
Applicant PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactNancy M Johansen
CorrespondentNancy M Johansen
PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeKHO  
CFR Regulation Number862.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-07
Decision Date1993-06-07

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