K092649 is an FDA 510(k) clearance for the ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190. This device is classified as a Test, Natriuretic Peptide (Class II - Special Controls, product code NBC).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 4, 2010, 160 days after receiving the submission on August 28, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117.
| 510(k) Number | K092649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2009 |
| Decision Date | February 04, 2010 |
| Days to Decision | 160 days |
| Submission Type | Special |
| 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 |