K033606 is an FDA 510(k) clearance for the ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST. This device is classified as a Test, Natriuretic Peptide (Class II - Special Controls, product code NBC).
Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on January 30, 2004, 74 days after receiving the submission on November 17, 2003.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117.
| 510(k) Number | K033606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2003 |
| Decision Date | January 30, 2004 |
| 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 |