The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Vigil Ii.
| Device ID | K920845 |
| 510k Number | K920845 |
| Device Name: | VIGIL II |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| 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 | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1992-12-07 |