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510(k) K855238

BIOTEL (TM)/UTI by American Diagnostic Corp. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1986
Date Received
December 31, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
Review Panel
CH
Submission Type

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