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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
510(k) Number K855238
Device Name BIOTEL (TM)/UTI
Applicant
AMERICAN DIAGNOSTIC CORP.
P.O. BOX 89
WHEATON,  IL  60189
Applicant Contact CRAIG BONDA
Correspondent
AMERICAN DIAGNOSTIC CORP.
P.O. BOX 89
WHEATON,  IL  60189
Correspondent Contact CRAIG BONDA
Regulation Number862.1510
Classification Product Code
JMT  
Date Received12/31/1985
Decision Date 05/09/1986
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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