The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx3.
| Device ID | K864236 |
| 510k Number | K864236 |
| Device Name: | SYNCHRON CX3 |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 2500 HARBOR BLVD. P.O. BOX 3100 Fullerton, CA 92634 |
| Contact | Jack E Sorokin |
| Correspondent | Jack E Sorokin BECKMAN INSTRUMENTS, INC. 2500 HARBOR BLVD. P.O. BOX 3100 Fullerton, CA 92634 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1986-12-31 |