K833385 is an FDA 510(k) clearance for the N-ACETYLPROCAINAMIDE CALIBRATOR. This device is classified as a Coating, Liquid, Glc (Class I - General Controls, product code DLG).
Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1983, 78 days after receiving the submission on September 29, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K833385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1983 |
| Decision Date | December 16, 1983 |
| Days to Decision | 78 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 |