510(k) K080269
K080269 is an FDA 510(k) premarket notification submitted by Biosite Incorporated for the device "TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS". The FDA issued a decision of Substantially Equivalent on June 6, 2008. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Biosite Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2008
- Date Received
- February 1, 2008
- 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