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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Progesterone
510(k) Number K854094
Device Name IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
Applicant
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Applicant Contact BARRY J BURNS
Correspondent
Immuchem Corp.
P.O. Box 6227
2015 E. University Dr.
Carson,  CA  90746
Correspondent Contact BARRY J BURNS
Regulation Number862.1620
Classification Product Code
JLS  
Date Received10/07/1985
Decision Date 02/28/1986
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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