The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Beckman Cholesterol Reagent.
| Device ID | K934046 |
| 510k Number | K934046 |
| Device Name: | BECKMAN CHOLESTEROL REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Contact | William T Ryan |
| Correspondent | William T Ryan BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 SOUTH KRAEMER BLVD. Brea, CA 92621 -6209 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1993-10-28 |