K993022 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS. 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 9, 1999, 61 days after receiving the submission on September 9, 1999.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K993022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1999 |
| Decision Date | November 09, 1999 |
| Days to Decision | 61 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 |