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FDA 510(k), K041194, ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
FDA 510(k), K041194, ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
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510(K) Number: K041194
Device Name: ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
Manufacturer:
Device Classification Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation Number: 862.1660
Classification Product Code: JJX
Date Received: 05/06/2004
Decision Date: 08/16/2004
Regulation Medical Specialty: Clinical Chemistry
Device Name: ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
Manufacturer:
Device Classification Name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation Number: 862.1660
Classification Product Code: JJX
Date Received: 05/06/2004
Decision Date: 08/16/2004
Regulation Medical Specialty: Clinical Chemistry
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