The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Vigil Prx Chemistry Control.
| Device ID | K936184 |
| 510k Number | K936184 |
| Device Name: | VIGIL PRX CHEMISTRY CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-27 |
| Decision Date | 1994-04-15 |