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510(k) K050504

VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS by Maine Standards Co. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2005
Date Received
February 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K053247 — VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET (January 13, 2006)

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