K844070 is an FDA 510(k) clearance for the TDX SALICYLATE. This device is classified as a Colorimetry, Salicylate (Class II - Special Controls, product code DKJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 27, 1984, 40 days after receiving the submission on October 18, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K844070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 1984 |
| Decision Date | November 27, 1984 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |