K983209 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I. This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 4, 1998, 51 days after receiving the submission on September 14, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.
| 510(k) Number | K983209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1998 |
| Decision Date | November 04, 1998 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DKB — Calibrators, Drug Mixture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3200 |