AMS GRAM-POSITIVE IDENT. CARD

Discs, Strips And Reagents, Microorganism Differentiation

VITEK SYSTEMS, INC.

The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Ams Gram-positive Ident. Card.

Pre-market Notification Details

Device IDK834389
510k NumberK834389
Device Name:AMS GRAM-POSITIVE IDENT. CARD
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant VITEK SYSTEMS, 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 Received1983-12-14
Decision Date1984-03-09

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