K993473 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DRUG CALIBRATOR 2. This device is classified as a Calibrators, Drug Specific (Class II - Special Controls, product code DLJ).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 26, 1999, 43 days after receiving the submission on October 14, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K993473 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 1999 |
| Decision Date | November 26, 1999 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DLJ — Calibrators, Drug Specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |