Panels › Immunology › Product code DGC · Class 2
Ige, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (114 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in DGC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 16 | 0 |
| Ventrex Laboratories, Inc. | 12 | 0 |
| Kallestad Laboratories, Inc. | 8 | 0 |
| Diagnostic Products Corp. | 6 | 0 |
| Hybritech, Inc. | 4 | 0 |
| Allergenetics | 3 | 0 |
| Mast Immunosystems | 3 | 0 |
| Quidel Corp. | 3 | 0 |
| 3M Company | 2 | 0 |
| Abbott Laboratories | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 1982 | K820978 | VENTRE/SPEC ALLERGEN CONTROL-INHALANT Ventrex Laboratories, Inc. | DGC |
| Jun 11, 1982 | K820977 | VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD Ventrex Laboratories, Inc. | DGC |
| Jun 10, 1982 | K821615 | VAST VENTREX PD IGE RIA TEST SET Ventrex Laboratories, Inc. | DGC |
| May 5, 1982 | K820897 | VENTRE/SPEC IGE CONTROLS Ventrex Laboratories, Inc. | DGC |
| Apr 21, 1982 | K820896 | VENTREX 125I ANTI-IGE ALLERGY ISOTOPE Ventrex Laboratories, Inc. | DGC |
| Dec 31, 1981 | K813189 | PHADEBAS/PHADEZYM IGE REAGENTS Pharmacia, Inc. | DGC |
| Jul 10, 1981 | K811559 | VENTRE/SEP IGE RIA TEST SET Ventrex Laboratories, Inc. | DGC |
| Jun 24, 1981 | K811545 | KALLESTAD QUANTITOPE LOW LEVEL IGE REAG Kallestad Laboratories, Inc. | DGC |
| May 29, 1981 | K802913 | TAN DEM* - IGE KIT Hybritech, Inc. | DGC |
| Mar 20, 1981 | K810507 | PHADEZYM IGE PRIST TEST Pharmacia, Inc. | DGC |
| May 20, 1980 | K801019 | 125I-IGE RADIOIMMUNOASSAY KIT Bio-Ria | DGC |
| Feb 8, 1979 | K781904 | RIA KIT, QUANTITOPE IGE Kallestad Laboratories, Inc. | DGC |
| Jun 6, 1978 | K780753 | LAS-R HUMAN IGE TEST Hyland Therapeutic Div., Travenol Laboratories | DGC |
| Jul 15, 1977 | K771238 | RID PLATES & INTENSI. FOR HUMAN IGE ETC G.D. Searle and Co. | DGC |
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