K983709 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1. This device is classified as a Drug Mixture Control Materials (Class I - General Controls, product code DIF).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on October 28, 1998, 7 days after receiving the submission on October 21, 1998.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.
| 510(k) Number | K983709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1998 |
| Decision Date | October 28, 1998 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIF — Drug Mixture Control Materials |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3280 |