The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx Systems Lipase (lipa) Reagent.
| Device ID | K970905 |
| 510k Number | K970905 |
| Device Name: | SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea, CA 92621 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. M.S. W-351 Brea, CA 92621 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-06-04 |
| Summary: | summary |