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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 K871317
Device Name FOLLICLE STIMULATING HORMONE (HFSH)
Applicant
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact BURNS, PHD
Correspondent
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact BURNS, PHD
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received04/02/1987
Decision Date 05/20/1987
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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