OPTOCHIN DIAGNOSTIC DISC

Discs, Strips And Reagents, Microorganism Differentiation

OXOID U.S.A., INC.

The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Optochin Diagnostic Disc.

Pre-market Notification Details

Device IDK802496
510k NumberK802496
Device Name:OPTOCHIN DIAGNOSTIC DISC
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-10
Decision Date1980-11-12

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