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FDA 510(k)

RAMP RSV ASSAY

K-Number: K091235 · 2009-07-24

ApplicantResponse Biomedical Corp.
Decision Date2009-07-24
Product CodeGQG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAMP RSV 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 2009-07-24 under 510(k) number K091235. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAMP RSV ASSAY?

RAMP RSV ASSAY is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Response Biomedical Corp.. The 510(k) number is K091235.

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

RAMP RSV ASSAY received FDA 510(k) clearance on 2009-07-24, under 510(k) number K091235.

Who is the listed applicant for RAMP RSV 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 RSV ASSAY?

The FDA product code for RAMP RSV ASSAY is GQG.

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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 ASSAYK063662RAMP NT-PROBNP ASSAYK071591RAMP INFLUENZA A/B ASSAYK033745RAMP TROPONIN I ASSAYK033747RAMP CK-MB ASSAYK012040RAMP MYOGLOBIN ASSAY

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Related Devices (Code: GQG)

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.

K253318Clungene RSV Antigen Rapid TestHangzhou Clongene Biotech Co., Ltd.K240280Nano-Check™ RSV TestNano-Ditech CorporationK162911Sofia RSV FIA on Sofia 2 analyzerQuidel CorporationK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVBecton, Dickinson & COK132456BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSVBecton, Dickinson and CompanyK130398SOFIA(R) RSV FIAQuidel 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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