The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Cx Systems (lap) Reagent Kit.
| Device ID | K895850 |
| 510k Number | K895850 |
| Device Name: | SYNCHRON CX SYSTEMS (LAP) REAGENT KIT |
| Classification | L-leucine-4-nitroanilide (colorimetric), Leucine Arylamidase |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | JGG |
| CFR Regulation Number | 862.1460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-05 |