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 |
|---|---|---|---|
| Feb 12, 1987 | K870153 | ALLERGEN SPECIFIC IGG4 CONTROL SERA 3M Company | DHB |
| Feb 12, 1987 | K864104 | ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST 3M Company | DHB |
| Feb 6, 1987 | K870152 | ALLERGEN SPECIFIC CONTROLS 3M Company | DHB |
| Dec 22, 1986 | K863967 | SPECIFIC IGE FAST(TM) TEST II 3M Company | DHB |
| Dec 15, 1986 | K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT Immuno Nuclear Corp. | DHB |
| Dec 3, 1986 | K863794 | 3M IGG4 FAST TEST PACKAGE 3M Company | DHB |
| Dec 3, 1986 | K863394 | RAPID SPECIFIC IGE PROCEDURE Allertec, Inc. | DHB |
| Dec 1, 1986 | K863973 | ELM ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Oct 29, 1986 | K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Oct 3, 1986 | K863036 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBE Pharmacia, Inc. | DHB |
| Oct 1, 1986 | K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Sep 17, 1986 | K863355 | PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA Pharmacia, Inc. | DHB |
| Sep 16, 1986 | K862901 | VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. | DHB |
| Sep 15, 1986 | K863098 | MEADOW FESCUE ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Aug 19, 1986 | K862266 | MAPLE ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Aug 15, 1986 | K862939 | ORCHARD GRASS ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Aug 15, 1986 | K862938 | JUNE GRASS ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Aug 15, 1986 | K862265 | COTTONWOOD ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Aug 15, 1986 | K862176 | RUSSIAN THISTLE ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Jul 3, 1986 | K862264 | ENGLISH PLAINTAIN ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Jul 3, 1986 | K862173 | PERENNIAL RYE ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Jun 20, 1986 | K862175 | WHITE OAK ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| May 15, 1986 | K854756 | SHORT RAGWEED ALLERGEN DISC Immuno Nuclear Corp. | DHB |
| Apr 25, 1986 | K861184 | PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Apr 22, 1986 | K860027 | FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY Alerchek, Inc. | DHB |
| Apr 22, 1986 | K855053 | THABEST-IGE Visual Diagnostics, Inc. | DHB |
| Apr 22, 1986 | K854865 | PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5 Pharmacia, Inc. | DHB |
| Feb 13, 1986 | K854939 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. | DHB |
| Nov 18, 1985 | K853969 | PHADEBAS RAST TEST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Oct 16, 1985 | K850895 | VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY Ventrex Laboratories, Inc. | DHB |
| Sep 19, 1985 | K853456 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. | DHB |
| Sep 19, 1985 | K852794 | ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. | DHB |
| Jul 15, 1985 | K852189 | PHADEBAS RAST TEST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Jun 27, 1985 | K852263 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES Pharmacia, Inc. | DHB |
| May 28, 1985 | K851512 | ALLERGENETICS IGE FAST TEST Allergenetics | DHB |
| May 21, 1985 | K851273 | PHADEBAS RAST PHADEZYM RAST ALLERTUBES Pharmacia, Inc. | DHB |
| Apr 12, 1985 | K844629 | MAST LUMINESCENT ALLERGY SYSTEM Mast Immunosystems | DHB |
| Apr 12, 1985 | K843694 | MAST ALLERGY SYSTEM Mast Immunosystems | DHB |
| Mar 21, 1985 | K845032 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Oct 4, 1984 | K843302 | NEW ALLERG. COATED MICROFILTER WELL STRI Diagnostic Reagent Tech. | DHB |
| Jul 2, 1984 | K842457 | PHADEXACT SERUM, ALLERGEN SPECIFIC IGE Pharmacia, Inc. | DHB |
| May 11, 1984 | K841516 | VENTRESCREEN, MULTIPLE ALLERGEN DISCS Ventrex Laboratories, Inc. | DHB |
| Apr 18, 1984 | K840670 | PHADEBAS RAST PHADEZYM MIX ALLERG Pharmacia, Inc. | DHB |
| Apr 17, 1984 | K840876 | PHADEBAS RAST TEST -ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Apr 4, 1984 | K834526 | MAST INHALANT PROFILE Mast Immunosystems | DHB |
| Apr 2, 1984 | K840537 | RAST ALLERGO SORBENT TEST Pharmacia, Inc. | DHB |
| Mar 12, 1984 | K833418 | CHYMOFAST TEST Allergenetics | DHB |
| Mar 9, 1984 | K840360 | ALLERCOAT MULTISCREEN DISCS Kallestad Laboratories, Inc. | DHB |
| Feb 10, 1984 | K834598 | LIGHT TEST Hemogenetics, Inc. | DHB |
| Jan 4, 1984 | K833885 | MAST INHALANT PROFILE Mast Immunosystems | DHB |
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