GROUP A STREP, BETA-STREP

Antisera, All Groups, Streptococcus Spp.

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Group A Strep, Beta-strep.

Pre-market Notification Details

Device IDK884750
510k NumberK884750
Device Name:GROUP A STREP, BETA-STREP
ClassificationAntisera, All Groups, Streptococcus Spp.
Applicant AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
ContactRaymond Gould
CorrespondentRaymond Gould
AMPCOR, INC. 510 HERON DRIVE, BLDG 306 P.O. BOX 521 Bridgeport,  NJ  08014
Product CodeGTZ  
CFR Regulation Number866.3740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-14
Decision Date1988-12-22

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