K080578 is an FDA 510(k) clearance for the DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA. This device is classified as a Test, Natriuretic Peptide (Class II - Special Controls, product code NBC).
Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on May 16, 2008, 74 days after receiving the submission on March 3, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117.
| 510(k) Number | K080578 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2008 |
| Decision Date | May 16, 2008 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBC — Test, Natriuretic Peptide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1117 |