The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Vigil Lipid Control.
| Device ID | K974452 |
| 510k Number | K974452 |
| Device Name: | VIGIL LIPID CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Richard T Ross |
| Correspondent | Richard T Ross BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-25 |
| Decision Date | 1997-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222925 | K974452 | 000 |
| 15099590222918 | K974452 | 000 |
| 15099590222901 | K974452 | 000 |
| 15099590221270 | K974452 | 000 |