FDA 510(k)

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I

K-Number: K034055 · 2004-01-21

Decision Date2004-01-21

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 2004-01-21 under 510(k) number K034055. 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 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I?

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I is a medical device that received FDA 510(k) clearance on 2004-01-21. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K034055.

When did IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I receive FDA 510(k) clearance?

IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I received FDA 510(k) clearance on 2004-01-21, under 510(k) number K034055.

Who is the listed applicant for IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I?

The FDA product code for IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I is JHX.

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Other records listing Diagnostic Products Corp. as applicant

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Related Devices (Code: JHX)

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps K120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical Aps K081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku Iatron K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.

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.