The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Vigil Protein Control.
| Device ID | K982224 |
| 510k Number | K982224 |
| Device Name: | VIGIL PROTEIN CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Richard T Ross |
| Correspondent | Richard T Ross BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-24 |
| Decision Date | 1998-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590226916 | K982224 | 000 |
| 15099590223045 | K982224 | 000 |
| 15099590222611 | K982224 | 000 |