The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Hdl Cholesterol Reagent.
| Device ID | K934045 |
| 510k Number | K934045 |
| Device Name: | BECKMAN HDL CHOLESTEROL REAGENT |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| 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 | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-19 |
| Decision Date | 1993-10-14 |