510(k) K063662
K063662 is an FDA 510(k) premarket notification submitted by Response Biomedical Corp. for the device "RAMP NT-PROBNP ASSAY". The FDA issued a decision of Substantially Equivalent on July 21, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Response Biomedical Corp. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2008
- Date Received
- December 8, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Natriuretic Peptide
- Device Class
- Class II
- Regulation Number
- 862.1117
- Review Panel
- CH
- Submission Type