K894528 is an FDA 510(k) clearance for the FPR PHENYTOIN CALIBRATOR KIT. This device is classified as a Coating, Liquid, Glc (Class I - General Controls, product code DLG).
Submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 25, 1989, 67 days after receiving the submission on July 20, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K894528 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1989 |
| Decision Date | September 25, 1989 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DLG — Coating, Liquid, Glc |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2250 |