POLYSTYRENE MICROTITER WELL IMMUNOSOR

Ige, Antigen, Antiserum, Control

DIAGNOSTIC REAGENT TECH.

The following data is part of a premarket notification filed by Diagnostic Reagent Tech. with the FDA for Polystyrene Microtiter Well Immunosor.

Pre-market Notification Details

Device IDK832345
510k NumberK832345
Device Name:POLYSTYRENE MICROTITER WELL IMMUNOSOR
ClassificationIge, Antigen, Antiserum, Control
Applicant DIAGNOSTIC REAGENT TECH. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDGC  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-18
Decision Date1983-11-25

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