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FDA 510(k)

RAMP CK-MB ASSAY

K-Number: K033747 · 2004-05-17

ApplicantResponse Biomedical Corp.
Decision Date2004-05-17
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RAMP CK-MB ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Response Biomedical Corp.. It received FDA 510(k) clearance on 2004-05-17 under 510(k) number K033747. 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 RAMP CK-MB ASSAY?

RAMP CK-MB ASSAY is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Response Biomedical Corp.. The 510(k) number is K033747.

When did RAMP CK-MB ASSAY receive FDA 510(k) clearance?

RAMP CK-MB ASSAY received FDA 510(k) clearance on 2004-05-17, under 510(k) number K033747.

Who is the listed applicant for RAMP CK-MB ASSAY?

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

What is the FDA product code for RAMP CK-MB ASSAY?

The FDA product code for RAMP CK-MB ASSAY is JHX.

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Other records listing Response Biomedical Corp. 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.

K093116MODIFICATION TO: RAMP INFLUENZA A/B ASSAYK091235RAMP RSV ASSAYK063662RAMP NT-PROBNP ASSAYK071591RAMP INFLUENZA A/B ASSAYK033745RAMP TROPONIN I ASSAYK012040RAMP MYOGLOBIN ASSAY

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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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