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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 K844347
Device Name FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT
Applicant
Fisher Diagnostics
526 Route 303
Applicant Contact CHARLES B BREUER
Correspondent
Fisher Diagnostics
526 Route 303
Correspondent Contact CHARLES B BREUER
Regulation Number862.1155
Classification Product Code
JHJ  
Date Received11/09/1984
Decision Date 01/23/1985
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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