K894327 is an FDA 510(k) clearance for the EMIT D.A.U. LOW & MEDIUM CALIBRATOR A. This device is classified as a Plate, Cellulose, Tlc (Class I - General Controls, product code DKG).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 3, 1989, 20 days after receiving the submission on July 14, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2270.
| 510(k) Number | K894327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DKG — Plate, Cellulose, Tlc |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2270 |