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510(k) K170118

Scanostics UTI Check Application Test System by Teco Diagnostics — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2017
Date Received
January 13, 2017
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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