RPR TEST FOR SYPHILIS IN SERUM OR PLASMA

Antigens, Nontreponemal, All

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Rpr Test For Syphilis In Serum Or Plasma.

Pre-market Notification Details

Device IDK880477
510k NumberK880477
Device Name:RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
ClassificationAntigens, Nontreponemal, All
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 CodeGMQ  
CFR Regulation Number866.3820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-02-04
Decision Date1988-03-30

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