The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Carbamazepine Test System.
| Device ID | K955644 |
| 510k Number | K955644 |
| Device Name: | SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 S. KRAEMER BLVD., W-337 Brea, CA 92622 -8000 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 S. KRAEMER BLVD., W-337 Brea, CA 92622 -8000 |
| Product Code | KLT |
| Subsequent Product Code | DIP |
| Subsequent Product Code | DKB |
| Subsequent Product Code | KLS |
| Subsequent Product Code | LCD |
| Subsequent Product Code | LCQ |
| Subsequent Product Code | LCR |
| Subsequent Product Code | LFN |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590232184 | K955644 | 000 |
| 15099590232078 | K955644 | 000 |
| 15099590232061 | K955644 | 000 |
| 15099590232030 | K955644 | 000 |
| 15099590222185 | K955644 | 000 |
| 15099590221287 | K955644 | 000 |
| 15099590200046 | K955644 | 000 |