PREGNANCY (HCG) CARD & LIQUID TEST

Agglutination Method, Human Chorionic Gonadotropin

AMPCOR, INC.

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

Pre-market Notification Details

Device IDK880163
510k NumberK880163
Device Name:PREGNANCY (HCG) CARD & LIQUID TEST
ClassificationAgglutination Method, Human Chorionic Gonadotropin
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 CodeJHJ  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-01-13
Decision Date1988-05-17

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