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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 K850604
Device Name PRECO PREGNANCY RAPID CARD TEST, HEM #2028
Applicant
Preco, Inc.
9 Post Rd.
Oakland,  NJ  07436
Applicant Contact JOHN S PAXOS
Correspondent
Preco, Inc.
9 Post Rd.
Oakland,  NJ  07436
Correspondent Contact JOHN S PAXOS
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received02/15/1985
Decision Date 04/08/1985
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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