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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 K811536
Device Name DIRECT TESTOSTERONE RIA
Applicant
Immuchem Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuchem Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received06/01/1981
Decision Date 06/18/1981
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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