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510(k) K081360

PATHFAST CK-MB-II, PATHFAST MYO-II by Mitsubishi Kagaku Iatron — Product Code JHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2009
Date Received
May 15, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometric Method, Cpk Or Isoenzymes
Device Class
Class II
Regulation Number
862.1215
Review Panel
CH
Submission Type

Other clearances by Mitsubishi Kagaku Iatron

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  • K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS (February 5, 2008)

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  • K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS C (September 8, 2005)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K033747 — RAMP CK-MB ASSAY (May 17, 2004)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND (January 17, 2003)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)