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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K894169
Device Name BIOTEL MICROALBUMINURIA (TM)
Applicant
American Diagnostic Corp.
1301 W. 22nd St., Suite
312
Oak Brook,  IL  60521
Applicant Contact CRAIG BONDA
Correspondent
American Diagnostic Corp.
1301 W. 22nd St., Suite
312
Oak Brook,  IL  60521
Correspondent Contact CRAIG BONDA
Regulation Number862.1645
Classification Product Code
JIR  
Date Received06/15/1989
Decision Date 09/18/1989
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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