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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K822140
Device Name IMMUCHEM COVALENT-COAT
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 Number862.1245
Classification Product Code
JKC  
Date Received07/20/1982
Decision Date 08/05/1982
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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