RF CARD TEST & RF LIQUID TEST

System, Test, Rheumatoid Factor

AMPCOR, INC.

The following data is part of a premarket notification filed by Ampcor, Inc. with the FDA for Rf Card Test & Rf Liquid Test.

Pre-market Notification Details

Device IDK880164
510k NumberK880164
Device Name:RF CARD TEST & RF LIQUID TEST
ClassificationSystem, Test, Rheumatoid Factor
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 CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-13
Decision Date1988-02-10

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