MODIFICATION TO: RAMP INFLUENZA A/B ASSAY— 510(k) K093116

Name: FDA 510(k) clearance K093116
Creator: U.S. Food and Drug Administration
Published: 2009-10-21

Substantially Equivalent

Response Biomedical Corp.

FDA 510(k) clearance K093116 for MODIFICATION TO: RAMP INFLUENZA A/B ASSAY, Substantially Equivalent on 2009-10-21. Applicant: Response Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Response Biomedical Corp.
Product code: Code PSZ
Device class: Class 2
Regulation: 21 CFR 866.3328
Advisory panel: Microbiology
Date received: 2009-10-02
Decision date: 2009-10-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Vancouver, B.C, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.