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 |
|---|---|---|---|
| Jul 27, 1992 | K922538 | VENTREX ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
| Mar 13, 1992 | K914554 | SPECIFIC IGE EIA-TURBO ASSAY Ventrex Laboratories, Inc. | DHB |
| Feb 21, 1992 | K913833 | VENTREX ALLERGEN DISC Ventrex Laboratories, Inc. | DHB |
| Dec 9, 1991 | K914850 | CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE Mast Immunosystems | DHB |
| Nov 29, 1991 | K913150 | ABBOTT MATRIX AERO PLUS SYSTEM Abbott Laboratories | DHB |
| Nov 22, 1991 | K913212 | 3M IGE SINGLE POINT FAST TEST Whittaker Bioproducts, Inc. | DHB |
| Nov 22, 1991 | K912294 | ALLERGY INFORMATION MANAGER Diagnostic Products Corp. | DHB |
| Oct 2, 1991 | K913892 | FASTTECH SYSTEM II 3M Diagnostic Systems, Inc. | DHB |
| Aug 12, 1991 | K911903 | ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA Pharmacia, Inc. | DHB |
| Jul 31, 1991 | K912582 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. | DHB |
| Apr 17, 1991 | K894227 | ALLERGEN MODULES FOR ALASTAT TM Diagnostic Products Corp. | DHB |
| Apr 5, 1991 | K910292 | MAST CLA ALLERGY SYSTEM Mast Immunosystems | DHB |
| Mar 22, 1991 | K905054 | CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER Ciba Corning Diagnostics Corp. | DHB |
| Mar 5, 1991 | K910517 | CAP SYSTEM RAST ASM/RIA AND ASM/FEIA Pharmacia, Inc. | DHB |
| Feb 7, 1991 | K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. | DHB |
| Jan 30, 1991 | K910075 | SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE Diagnostic Products Corp. | DHB |
| Jan 14, 1991 | K905162 | QUIDEL TOTAL IGE POSITIVE CONTROL SERUM Quidel Corp. | DHB |
| Dec 13, 1990 | K905176 | POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN Quidel Corp. | DHB |
| Dec 7, 1990 | K904330 | TURBO-RAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. | DHB |
| Nov 29, 1990 | K904661 | IVT RAST TRACER In Vitro Technologies, Inc. | DHB |
| Nov 21, 1990 | K903637 | ALRGN SET Ciba Corning Diagnostics Corp. | DHB |
| Oct 15, 1990 | K903742 | ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE Diagnostic Products Corp. | DHB |
| Sep 4, 1990 | K902576 | ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA Diagnostic Products Corp. | DHB |
| Jan 22, 1990 | K894190 | PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA Pharmacia, Inc. | DHB |
| Jan 10, 1990 | K897145 | 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) 3M Company | DHB |
| Jan 10, 1990 | K896902 | ENZYMUN TEST R IGE Boehringer Mannheim Corp. | DHB |
| Dec 18, 1989 | K896852 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. | DHB |
| Dec 8, 1989 | K896694 | VENTREZYME VAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. | DHB |
| Dec 4, 1989 | K896592 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY Ciba Corning Diagnostics Corp. | DHB |
| Jul 28, 1989 | K894253 | QUIDEL FOOD ALLERGEN SCREEN Quidel Corp. | DHB |
| Jun 2, 1989 | K893132 | PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC Pharmacia, Inc. | DHB |
| May 9, 1989 | K891135 | PHADIATOP PAEDIATRIC RIA AND EIA Pharmacia, Inc. | DHB |
| May 4, 1989 | K892409 | QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN Quidel Corp. | DHB |
| Feb 17, 1989 | K884501 | QUIDEL FOOD ALLERGY SCREEN Quidel Corp. | DHB |
| Feb 7, 1989 | K885269 | ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS Dexall Biomedical Labs, Inc. | DHB |
| Jan 23, 1989 | K884883 | 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) Diagnostic Products Corp. | DHB |
| Jan 11, 1989 | K884923 | MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) Diagnostic Products Corp. | DHB |
| Jan 4, 1989 | K885065 | IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) 3M Company | DHB |
| Nov 4, 1988 | K883537 | QM300 CONTROL E Kallestad Diag, A Div. of Erbamont, Inc. | DHB |
| Oct 27, 1988 | K884185 | CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY Ciba Corning Diagnostics Corp. | DHB |
| Oct 27, 1988 | K883371 | MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) 3M Company | DHB |
| Oct 18, 1988 | K883666 | QUIDEL ALLERGY SCREEN Quidel Corp. | DHB |
| Sep 22, 1988 | K883616 | SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) Diagnostic Products Corp. | DHB |
| Sep 7, 1988 | K883273 | DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) 3M Company | DHB |
| Aug 10, 1988 | K881899 | SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. Diagnostic Products Corp. | DHB |
| Jun 14, 1988 | K875110 | HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC Incstar Corp. | DHB |
| May 16, 1988 | K880899 | PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA Pharmacia, Inc. | DHB |
| May 11, 1988 | K880221 | INCSTAR'S PIGWEED ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K880168 | INCSTAR'S BIRCH ALLERGEN DISC Incstar Corp. | DHB |
| May 11, 1988 | K874883 | WALNUT ALLERGEN DISC Incstar Corp. | DHB |
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