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FDA 510(k)

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER

K-Number: K000716 · 2000-03-20

ApplicantBeckman Coulter, Inc.
Decision Date2000-03-20
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2000-03-20 under 510(k) number K000716. 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 ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER?

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 2000-03-20. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K000716.

When did ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 2000-03-20, under 510(k) number K000716.

Who is the listed applicant for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER?

The FDA product code for ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER is JHX.

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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 ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS 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.

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