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510(k) K012829

STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS by Biocare Corp. — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2001
Date Received
August 23, 2001
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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