K942676 is an FDA 510(k) clearance for the SYNCHRON CX3 DELTA. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Beckman-Diagnostic Systems Group (Brea, US). The FDA issued a Cleared decision on November 2, 1994, 149 days after receiving the submission on June 6, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K942676 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1994 |
| Decision Date | November 02, 1994 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |