VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION

Kit, Anaerobic Identification

VITEK SYSTEMS, INC.

The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Anaerobe Identification Card, Modification.

Pre-market Notification Details

Device IDK910666
510k NumberK910666
Device Name:VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
ClassificationKit, Anaerobic Identification
Applicant VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
ContactDavid K Broadway
CorrespondentDavid K Broadway
VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
Product CodeJSP  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-11
Decision Date1991-04-03

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