K861615 is an FDA 510(k) clearance for the SALICYLATE REAGENT SET. This device is classified as a Colorimetry, Salicylate (Class II - Special Controls, product code DKJ).
Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on May 23, 1986, 24 days after receiving the submission on April 29, 1986.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3830.
| 510(k) Number | K861615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 1986 |
| Decision Date | May 23, 1986 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKJ — Colorimetry, Salicylate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3830 |