FDA 510(k)

ARCHITECT STAT CK-MB IMMUNOASSAY

K-Number: K041596 · 2004-07-21

Decision Date2004-07-21

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ARCHITECT STAT CK-MB IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2004-07-21 under 510(k) number K041596. 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 ARCHITECT STAT CK-MB IMMUNOASSAY?

ARCHITECT STAT CK-MB IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2004-07-21. The listed applicant is Fisher Diagnostics. The 510(k) number is K041596.

When did ARCHITECT STAT CK-MB IMMUNOASSAY receive FDA 510(k) clearance?

ARCHITECT STAT CK-MB IMMUNOASSAY received FDA 510(k) clearance on 2004-07-21, under 510(k) number K041596.

Who is the listed applicant for ARCHITECT STAT CK-MB IMMUNOASSAY?

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

What is the FDA product code for ARCHITECT STAT CK-MB IMMUNOASSAY?

The FDA product code for ARCHITECT STAT CK-MB IMMUNOASSAY is JHX.

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Other records listing Fisher Diagnostics as applicant

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls K070640ARCHITECT STAT TROPONIN-1; MYOGLOBIN K052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS K052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM K042924ARCHITECT STAT MYO IMMUNOASSAY K041192ARCHITECT STAT TROPONIN-I IMMUNOASSAY

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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

View on FDA Database →

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