Panels › Immunology › Product code DGP · Class 2
Ige, Fitc, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DGP
| Company | 510(k)s | Recalls |
|---|---|---|
| Allergenetics | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Intl. Diagnostic Technology | 1 | 0 |
| Sclavo, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 20, 1993 | K931224 | VIDAS TOTAL IGE (IGE) ASSAY Biomerieux Vitek, Inc. | DGP |
| Dec 3, 1986 | K863327 | IMMPULSE IGE ASSAY REAGENTS Sclavo, Inc. | DGP |
| Aug 28, 1984 | K842969 | ALLERGENETICS ALLER-SPECIFIC IGE SERUM Allergenetics | DGP |
| Aug 28, 1984 | K842749 | FIAX TOTAL IGE TEST KIT Intl. Diagnostic Technology | DGP |
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