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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 K844066
Device Name COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
Applicant
Clinetics Corp.
2991 Dow Ave.
Tustin,  CA  92680
Applicant Contact MARY FLEISCHACKER
Correspondent
Clinetics Corp.
2991 Dow Ave.
Tustin,  CA  92680
Correspondent Contact MARY FLEISCHACKER
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received10/18/1984
Decision Date 01/18/1985
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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