K882766 is an FDA 510(k) clearance for the EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95. This device is classified as a Coating, Liquid, Glc (Class I - General Controls, product code DLG).
Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on August 23, 1988, 48 days after receiving the submission on July 6, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2250.
| 510(k) Number | K882766 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1988 |
| Decision Date | August 23, 1988 |
| Days to Decision | 48 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 |