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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Testosterones And Dihydrotestosterone
510(k) Number K861679
Device Name SHBG IRMA KIT
Applicant
Farmos Group , Ltd.
C/O Mackler, Cooper And Marx
1220 L St., NW Suite 615
Washington,  DC  20005
Applicant Contact BRUCE F MACKLER,PHD
Correspondent
Farmos Group , Ltd.
C/O Mackler, Cooper And Marx
1220 L St., NW Suite 615
Washington,  DC  20005
Correspondent Contact BRUCE F MACKLER,PHD
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received05/01/1986
Decision Date 03/13/1987
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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