The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Vigil Plus Control.
| Device ID | K930850 |
| 510k Number | K930850 |
| Device Name: | BECKMAN VIGIL PLUS CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-18 |
| Decision Date | 1993-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590227357 | K930850 | 000 |
| 15099590227333 | K930850 | 000 |
| 15099590222604 | K930850 | 000 |