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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agglutination Method, Human Chorionic Gonadotropin
510(k) Number K880478
Device Name PREGNANCY BETA-HCG CARD & LIQUID TEST
Applicant
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Applicant Contact RAYMOND GOULD
Correspondent
Ampcor, Inc.
510 Heron Dr., Bldg. 306
P.O. Box 521
Bridgeport,  NJ  08014
Correspondent Contact RAYMOND GOULD
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received02/04/1988
Decision Date 04/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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