K070640 is an FDA 510(k) clearance for the ARCHITECT STAT TROPONIN-1; MYOGLOBIN. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on September 13, 2007, 190 days after receiving the submission on March 7, 2007.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K070640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2007 |
| Decision Date | September 13, 2007 |
| Days to Decision | 190 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |