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510(k) K042421

URITEK 151 URINE ANALYZER, MODEL TC-151 by Teco Diagnostics — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2005
Date Received
September 7, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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