The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Cx Lipase Reagent & Calibrator For Synchron Cx Systems.
| Device ID | K952180 |
| 510k Number | K952180 |
| Device Name: | CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| 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 | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1995-08-17 |