K121214 is an FDA 510(k) clearance for the ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on June 14, 2013, 417 days after receiving the submission on April 23, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K121214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2012 |
| Decision Date | June 14, 2013 |
| Days to Decision | 417 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |