Panels › Immunology › Product code DHB · Class 2
System, Test, Radioallergosorbent (Rast) Immunological
Regulation 866.5750
7510(k)s in 12 months (269 all time)
14recalls in 12 months (27 all time)
16recalls that name a 510(k)
Top companies in DHB
| Company | 510(k)s | Recalls |
|---|---|---|
| Pharmacia, Inc. | 39 | 0 |
| Diagnostic Products Corp. | 26 | 0 |
| Hycor Biomedical | 24 | 1 |
| Incstar Corp. | 25 | 0 |
| Phadia AB | 16 | 2 |
| Ventrex Laboratories, Inc. | 18 | 0 |
| Siemens Healthcare Diagnostics | 9 | 8 |
| Immuno Nuclear Corp. | 14 | 0 |
| 3M Company | 13 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 11 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 1983 | K832344 | POLYSTYRENE MICROTITER PLATE IMMUNO- Diagnostic Reagent Tech. | DHB |
| Sep 20, 1983 | K832217 | VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD Ventrex Laboratories, Inc. | DHB |
| Jun 8, 1983 | K831554 | NEIN ALLERGEN DISC IN VAST VENTREX TEST Ventrex Laboratories, Inc. | DHB |
| Jun 8, 1983 | K831442 | PHADEBAS & PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Apr 27, 1983 | K831091 | NEW ALLERGEN DISC -VAST VENTEX ALLERGY Ventrex Laboratories, Inc. | DHB |
| Apr 27, 1983 | K831045 | PHADEBAS & PHADEZYM RAST MIXED ALLERG Pharmacia, Inc. | DHB |
| Mar 24, 1983 | K823592 | PHADEBAS & PHADEZYM RAST TEST ALLERG Pharmacia, Inc. | DHB |
| Mar 10, 1983 | K830155 | PHADEBAS & PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Feb 25, 1983 | K823593 | INHALANT PROFILE-ALLERGEN-SPECIFIC IGE Mast Immunosystems | DHB |
| Feb 7, 1983 | K830170 | RIASSIST RAST DATA REDUCTION/QUALITY Ventrex Laboratories, Inc. | DHB |
| Jan 28, 1983 | K830096 | PHADEBAS & PHADEZYME RAST ALLERGEN DISC Pharmacia, Inc. | DHB |
| Dec 15, 1982 | K823470 | ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. | DHB |
| Aug 3, 1982 | K822141 | PHADEBAS RAST TEST Pharmacia, Inc. | DHB |
| Jun 23, 1982 | K821451 | VAST VENTREX ALLERGY SYSTEMS TESTS Ventrex Laboratories, Inc. | DHB |
| Apr 6, 1982 | K820029 | KALLESTAD RAST REAGENTS Kallestad Laboratories, Inc. | DHB |
| Sep 14, 1981 | K812414 | KALLESTAD 125I ANTISERUM TO HUMAN IGE Kallestad Laboratories, Inc. | DHB |
| Mar 11, 1981 | K810462 | PHADEZYM RAST TEST Pharmacia, Inc. | DHB |
| Dec 2, 1980 | K802556 | PHADEBAS RAST TEST Pharmacia, Inc. | DHB |
| Sep 2, 1977 | K771578 | PHADEBAS RAST PENICLLOYL G/V TEST Pharmacia, Inc. | DHB |
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