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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K873986
Device Name BETA-HCG ASSAY
Applicant
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact KAFADER II
Correspondent
Schiff & Co.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact KAFADER II
Regulation Number862.1155
Classification Product Code
DHA  
Date Received09/29/1987
Decision Date 02/02/1988
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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