The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Total Ige (ige) Assay.
| Device ID | K931224 |
| 510k Number | K931224 |
| Device Name: | VIDAS TOTAL IGE (IGE) ASSAY |
| Classification | Ige, Fitc, Antigen, Antiserum, Control |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vicki Anastasi |
| Correspondent | Vicki Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | DGP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-05-20 |