The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Enzyme Validator Set.
| Device ID | K951964 |
| 510k Number | K951964 |
| Device Name: | SYNCHRON ENZYME VALIDATOR SET |
| Classification | Calibrator, Primary |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-06-29 |