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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K831073
Device Name DAC-CEL HCG-MCA KIT RD52
Applicant
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wellcome Diagnostics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1370
Classification Product Code
CFL  
Date Received04/04/1983
Decision Date 09/01/1983
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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