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510(k) K061683

TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM by Roche Diagnostics Corp. — Product Code DDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2006
Date Received
June 15, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Myoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
Submission Type

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  • K033300 — VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN REAGENT PACK; CALIBRATORS; RANGE VERI (November 5, 2003)
  • K021229 — MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973 (June 28, 2002)
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