The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Vigil Serology Control Level C.
| Device ID | K010358 |
| 510k Number | K010358 |
| Device Name: | VIGIL SEROLOGY CONTROL LEVEL C |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-06 |
| Decision Date | 2001-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590227326 | K010358 | 000 |