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FDA 510(k)

PATHFAST CK-MB-II, PATHFAST MYO-II

K-Number: K081360 · 2009-08-17

ApplicantMitsubishi Kagaku Iatron
Decision Date2009-08-17
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PATHFAST CK-MB-II, PATHFAST MYO-II is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Kagaku Iatron. It received FDA 510(k) clearance on 2009-08-17 under 510(k) number K081360. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHFAST CK-MB-II, PATHFAST MYO-II?

PATHFAST CK-MB-II, PATHFAST MYO-II is a medical device that received FDA 510(k) clearance on 2009-08-17. The listed applicant is Mitsubishi Kagaku Iatron. The 510(k) number is K081360.

When did PATHFAST CK-MB-II, PATHFAST MYO-II receive FDA 510(k) clearance?

PATHFAST CK-MB-II, PATHFAST MYO-II received FDA 510(k) clearance on 2009-08-17, under 510(k) number K081360.

Who is the listed applicant for PATHFAST CK-MB-II, PATHFAST MYO-II?

The FDA 510(k) record lists Mitsubishi Kagaku Iatron as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATHFAST CK-MB-II, PATHFAST MYO-II?

The FDA product code for PATHFAST CK-MB-II, PATHFAST MYO-II is JHX.

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Other records listing Mitsubishi Kagaku Iatron as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K072288PATHFAST D-DIMERK083412PATHFAST HSCRPK072189PATHFAST NTPROBNP AND D-DIMER TESTS

Related Devices (Code: JHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.K041596ARCHITECT STAT CK-MB IMMUNOASSAYFisher Diagnostics

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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