Panels › Immunology › Product code DGO · Class 2
Ige, Peroxidase, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DGO
| Company | 510(k)s | Recalls |
|---|---|---|
| Diagnostic Reagent Tech. | 5 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Beckman Instruments, Inc. | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Calbiochem-Behring Corp. | 1 | 0 |
| Dexall Biomedical Labs, Inc. | 1 | 0 |
| Nichols Institute Diagnostics | 1 | 0 |
| Quidel Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 1995 | K943194 | IMMULITE(R) ALLERGY FOOD PANEL FP5E Diagnostic Products Corp. | DGO |
| Sep 14, 1992 | K920087 | IGE EIA TEST KIT The Binding Site, Ltd. | DGO |
| Apr 17, 1991 | K911511 | ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED Diagnostic Products Corp. | DGO |
| Jul 14, 1989 | K894039 | QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION Quidel Corp. | DGO |
| Jun 16, 1989 | K893125 | BECKMAN EPSILON(TM) IGE REAGENT KIT Beckman Instruments, Inc. | DGO |
| Sep 10, 1987 | K872801 | ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 Diagnostic Products Corp. | DGO |
| Mar 28, 1986 | K860851 | ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM Nichols Institute Diagnostics | DGO |
| Nov 7, 1985 | K853607 | ALLERG-E IGE ENZYME IMMUNOASSAY KIT Dexall Biomedical Labs, Inc. | DGO |
| Nov 21, 1983 | K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE Diagnostic Reagent Tech. | DGO |
| Oct 14, 1983 | K831987 | EPSILON IGE TEST KIT Beckman Instruments, Inc. | DGO |
| Jul 18, 1983 | K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- Diagnostic Reagent Tech. | DGO |
| Apr 8, 1983 | K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB Diagnostic Reagent Tech. | DGO |
| Apr 5, 1983 | K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR Diagnostic Reagent Tech. | DGO |
| May 7, 1982 | K821094 | IP SPECIFIC E Diagnostic Reagent Tech. | DGO |
| May 14, 1980 | K800995 | IMMUNOGLOBULIN E TEST KIT Calbiochem-Behring Corp. | DGO |
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