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510(k) K031873

I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET by I-Stat Corporation — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2003
Date Received
June 17, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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