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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K912804
Device Name FSH IRMA IMMUNOMAG
Applicant
PANTEX, DIV. BIO-ANALYSIS, INC.
1737 21ST ST.
SANTA MONICA,  CA  90404
Applicant Contact NEIL Y.CHIAMORI,PH.D
Correspondent
PANTEX, DIV. BIO-ANALYSIS, INC.
1737 21ST ST.
SANTA MONICA,  CA  90404
Correspondent Contact NEIL Y.CHIAMORI,PH.D
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received06/25/1991
Decision Date 08/12/1991
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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