RAMP RSV ASSAY— 510(k) K091235

Substantially Equivalent

Response Biomedical Corp.

FDA 510(k) clearance K091235 for RAMP RSV ASSAY, Substantially Equivalent on 2009-07-24. Applicant: Response Biomedical Corp.. Device class: 1.

Clearance details

Applicant: Response Biomedical Corp.
Product code: Code GQG
Device class: Class 1
Regulation: 21 CFR 866.3480
Advisory panel: Microbiology
Date received: 2009-04-27
Decision date: 2009-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, B.C, CA

Download summary PDF View on FDA.gov ↗

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More clearances from Response Biomedical Corp.

K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY2009-10-21
K063662 — RAMP NT-PROBNP ASSAY2008-07-21
K071591 — RAMP INFLUENZA A/B ASSAY2008-04-16
K033745 — RAMP TROPONIN I ASSAY2004-05-17
K033747 — RAMP CK-MB ASSAY2004-05-17

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