The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Synchron Cx3 Delta.
| Device ID | K942676 |
| 510k Number | K942676 |
| Device Name: | SYNCHRON CX3 DELTA |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Product Code | JJF |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEK |
| Subsequent Product Code | JFN |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-06 |
| Decision Date | 1994-11-02 |