K843908 is an FDA 510(k) clearance for the ABBOTT TDT EIA. This device is classified as a Diazo Colorimetry, Bilirubin (Class II - Special Controls, product code CIG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 3, 1985, 182 days after receiving the submission on October 3, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K843908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1984 |
| Decision Date | April 03, 1985 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |