The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchon Cx Delta Clin Syst (cx4, Cx5, Cx7 Delta).
| Device ID | K950958 |
| 510k Number | K950958 |
| Device Name: | SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Shei Hall |
| Correspondent | Shei Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-15 |
| Decision Date | 1995-05-08 |