K844947 is an FDA 510(k) clearance for the EMIT ANCILLARY REAGENTS. This device is classified as a Apparatus, High Pressure Liquid Chromatography (Class I - General Controls, product code KIE).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 28, 1985, 190 days after receiving the submission on December 20, 1984.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K844947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1984 |
| Decision Date | June 28, 1985 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KIE — Apparatus, High Pressure Liquid Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2260 |