K121985 is an FDA 510(k) clearance for the ARCHITECT TOTAL BILIRUBIN. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 1, 2013, 210 days after receiving the submission on July 6, 2012.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K121985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2012 |
| Decision Date | February 01, 2013 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |