The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Vigil Tdm Controls.
| Device ID | K972819 |
| 510k Number | K972819 |
| Device Name: | VIGIL TDM CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-29 |
| Decision Date | 1997-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590225421 | K972819 | 000 |
| 15099590225414 | K972819 | 000 |
| 15099590225315 | K972819 | 000 |