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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 K842555
Device Name DHEA-S DIRECT RIA KIT
Applicant
Biotecx Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Biotecx Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1245
Classification Product Code
JKC  
Date Received07/02/1984
Decision Date 08/07/1984
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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