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FDA 510(k)

RAMP MYOGLOBIN ASSAY

K-Number: K012040 · 2001-12-18

ApplicantResponse Biomedical Corp.
Decision Date2001-12-18
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RAMP MYOGLOBIN 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 2001-12-18 under 510(k) number K012040. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAMP MYOGLOBIN ASSAY?

RAMP MYOGLOBIN ASSAY is a medical device that received FDA 510(k) clearance on 2001-12-18. The listed applicant is Response Biomedical Corp.. The 510(k) number is K012040.

When did RAMP MYOGLOBIN ASSAY receive FDA 510(k) clearance?

RAMP MYOGLOBIN ASSAY received FDA 510(k) clearance on 2001-12-18, under 510(k) number K012040.

Who is the listed applicant for RAMP MYOGLOBIN 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 MYOGLOBIN ASSAY?

The FDA product code for RAMP MYOGLOBIN ASSAY is DDR.

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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 ASSAYK033747RAMP CK-MB ASSAY

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Related Devices (Code: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

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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