ONPG DISCS

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 Onpg Discs.

Pre-market Notification Details

Device IDK832307
510k NumberK832307
Device Name:ONPG DISCS
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 Received1983-07-14
Decision Date1983-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384034154 K832307 000

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