GONOCHEK II REAGENT TUBES

Discs, Strips And Reagents, Microorganism Differentiation

E-Y LABORATORIES, INC.

The following data is part of a premarket notification filed by E-y Laboratories, Inc. with the FDA for Gonochek Ii Reagent Tubes.

Pre-market Notification Details

Device IDK940162
510k NumberK940162
Device Name:GONOCHEK II REAGENT TUBES
ClassificationDiscs, Strips And Reagents, Microorganism Differentiation
Applicant E-Y LABORATORIES, INC. 107-127 N. AMPHLETT BLVD. San Mateo,  CA  94401
ContactLinda M Wertz
CorrespondentLinda M Wertz
E-Y LABORATORIES, INC. 107-127 N. AMPHLETT BLVD. San Mateo,  CA  94401
Product CodeJTO  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-12
Decision Date1994-09-09

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