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 |