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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 K852286
Device Name DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
Applicant
Sero-Immuno Diagnostics, Inc.
P.O. Box 616
Tucker,  GA  30085
Applicant Contact IRVING G KAGAN
Correspondent
Sero-Immuno Diagnostics, Inc.
P.O. Box 616
Tucker,  GA  30085
Correspondent Contact IRVING G KAGAN
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received05/29/1985
Decision Date 07/09/1985
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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