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510(k) K061730

OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 by Osmetech, Inc. — Product Code CEM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2006
Date Received
June 20, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

Other clearances by Osmetech, Inc.

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  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)

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