RAMP NT-PROBNP ASSAY— 510(k) K063662

Substantially Equivalent

Response Biomedical Corp.

FDA 510(k) clearance K063662 for RAMP NT-PROBNP ASSAY, Substantially Equivalent on 2008-07-21. Applicant: Response Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Response Biomedical Corp.
Product code: Code NBC
Device class: Class 2
Regulation: 21 CFR 862.1117
Advisory panel: Clinical Chemistry
Date received: 2006-12-08
Decision date: 2008-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnaby, British Columbia, 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.