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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 K972606
Device Name PREGNACOL PREGNANCY TEST
Applicant
IMMUNOSTICS, INC.
3505 SUNSET AVE.
OCEAN,  NJ  07712
Applicant Contact DAVID MYCOCK
Correspondent
IMMUNOSTICS, INC.
3505 SUNSET AVE.
OCEAN,  NJ  07712
Correspondent Contact DAVID MYCOCK
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received07/11/1997
Decision Date 08/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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