The following data is part of a premarket notification filed by Beckman with the FDA for Beckman Cholinesterase Reagent Kit.
| Device ID | K893583 |
| 510k Number | K893583 |
| Device Name: | BECKMAN CHOLINESTERASE REAGENT KIT |
| Classification | Colorimetry, Cholinesterase |
| Applicant | BECKMAN 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92621 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92621 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-09 |
| Decision Date | 1989-08-15 |