K943980 is an FDA 510(k) clearance for the IL TEST PHENYTION CALIBRATORS. This device is classified as a Enzyme Immunoassay, Diphenylhydantoin (Class II - Special Controls, product code DIP).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 1, 1995, 328 days after receiving the submission on June 7, 1994.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3350.
| 510(k) Number | K943980 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1994 |
| Decision Date | May 01, 1995 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIP — Enzyme Immunoassay, Diphenylhydantoin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3350 |