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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K832905
Device Name QUALITATIVE ENZYME IMMUNOASSAY-DETECT
Applicant
BTC DIAGNOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BTC DIAGNOSTICS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1155
Classification Product Code
LCX  
Date Received08/29/1983
Decision Date 02/03/1984
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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