FDA Product Code
FDA Product Code DHB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5750
510(k) Clearances — 269 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K864104 | ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST | 3M Company | 1987-02-12 | Traditional | PDF ↗ |
| K870153 | ALLERGEN SPECIFIC IGG4 CONTROL SERA | 3M Company | 1987-02-12 | Traditional | PDF ↗ |
| K870152 | ALLERGEN SPECIFIC CONTROLS | 3M Company | 1987-02-06 | Traditional | PDF ↗ |
| K863967 | SPECIFIC IGE FAST(TM) TEST II | 3M Company | 1986-12-22 | Traditional | PDF ↗ |
| K863743 | BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT | Immuno Nuclear Corp. | 1986-12-15 | Traditional | PDF ↗ |
| K863394 | RAPID SPECIFIC IGE PROCEDURE | Allertec, Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K863794 | 3M IGG4 FAST TEST PACKAGE | 3M Company | 1986-12-03 | Traditional | PDF ↗ |
| K863973 | ELM ALLERGEN DISC | Immuno Nuclear Corp. | 1986-12-01 | Traditional | PDF ↗ |
| K863844 | IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-10-29 | Traditional | PDF ↗ |
| K863036 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBE | Pharmacia, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K863123 | IMMUNO BIOTECH MUGWART ALLERGEN DISC | Immuno Nuclear Corp. | 1986-10-01 | Traditional | PDF ↗ |
| K863355 | PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA | Pharmacia, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K862901 | VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | 1986-09-16 | Traditional | PDF ↗ |
| K863098 | MEADOW FESCUE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-09-15 | Traditional | PDF ↗ |
| K862266 | MAPLE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-19 | Traditional | PDF ↗ |
| K862939 | ORCHARD GRASS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | Traditional | PDF ↗ |
| K862176 | RUSSIAN THISTLE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | Traditional | PDF ↗ |
| K862265 | COTTONWOOD ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | Traditional | PDF ↗ |
| K862938 | JUNE GRASS ALLERGEN DISC | Immuno Nuclear Corp. | 1986-08-15 | Traditional | PDF ↗ |
| K862264 | ENGLISH PLAINTAIN ALLERGEN DISC | Immuno Nuclear Corp. | 1986-07-03 | Traditional | PDF ↗ |
| K862173 | PERENNIAL RYE ALLERGEN DISC | Immuno Nuclear Corp. | 1986-07-03 | Traditional | PDF ↗ |
| K862175 | WHITE OAK ALLERGEN DISC | Immuno Nuclear Corp. | 1986-06-20 | Traditional | PDF ↗ |
| K854756 | SHORT RAGWEED ALLERGEN DISC | Immuno Nuclear Corp. | 1986-05-15 | Traditional | PDF ↗ |
| K861184 | PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS | Pharmacia, Inc. | 1986-04-25 | Traditional | PDF ↗ |
| K854865 | PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5 | Pharmacia, Inc. | 1986-04-22 | Traditional | PDF ↗ |
| K860027 | FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY | Alerchek, Inc. | 1986-04-22 | Traditional | PDF ↗ |
| K855053 | THABEST-IGE | Visual Diagnostics, Inc. | 1986-04-22 | Traditional | PDF ↗ |
| K854939 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES | Pharmacia, Inc. | 1986-02-13 | Traditional | PDF ↗ |
| K853969 | PHADEBAS RAST TEST ALLERGEN DISCS | Pharmacia, Inc. | 1985-11-18 | Traditional | PDF ↗ |
| K850895 | VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY | Ventrex Laboratories, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K852794 | ALLERCOAT ALLERGEN DISCS | Kallestad Laboratories, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K853456 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES | Pharmacia, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K852189 | PHADEBAS RAST TEST ALLERGEN DISCS | Pharmacia, Inc. | 1985-07-15 | Traditional | PDF ↗ |
| K852263 | PHADEBAS RAST/PHADEZYM RAST ALLERTUBES | Pharmacia, Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K851512 | ALLERGENETICS IGE FAST TEST | Allergenetics | 1985-05-28 | Traditional | PDF ↗ |
| K851273 | PHADEBAS RAST PHADEZYM RAST ALLERTUBES | Pharmacia, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K843694 | MAST ALLERGY SYSTEM | Mast Immunosystems | 1985-04-12 | Traditional | PDF ↗ |
| K844629 | MAST LUMINESCENT ALLERGY SYSTEM | Mast Immunosystems | 1985-04-12 | Traditional | PDF ↗ |
| K845032 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS | Pharmacia, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K843302 | NEW ALLERG. COATED MICROFILTER WELL STRI | Diagnostic Reagent Tech. | 1984-10-04 | Traditional | PDF ↗ |
| K842457 | PHADEXACT SERUM, ALLERGEN SPECIFIC IGE | Pharmacia, Inc. | 1984-07-02 | Traditional | PDF ↗ |
| K841516 | VENTRESCREEN, MULTIPLE ALLERGEN DISCS | Ventrex Laboratories, Inc. | 1984-05-11 | Traditional | PDF ↗ |
| K840670 | PHADEBAS RAST PHADEZYM MIX ALLERG | Pharmacia, Inc. | 1984-04-18 | Traditional | PDF ↗ |
| K840876 | PHADEBAS RAST TEST -ALLERGEN DISCS | Pharmacia, Inc. | 1984-04-17 | Traditional | PDF ↗ |
| K834526 | MAST INHALANT PROFILE | Mast Immunosystems | 1984-04-04 | Traditional | PDF ↗ |
| K840537 | RAST ALLERGO SORBENT TEST | Pharmacia, Inc. | 1984-04-02 | Traditional | PDF ↗ |
| K833418 | CHYMOFAST TEST | Allergenetics | 1984-03-12 | Traditional | PDF ↗ |
| K840360 | ALLERCOAT MULTISCREEN DISCS | Kallestad Laboratories, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K834598 | LIGHT TEST | Hemogenetics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833885 | MAST INHALANT PROFILE | Mast Immunosystems | 1984-01-04 | Traditional | PDF ↗ |
| K832344 | POLYSTYRENE MICROTITER PLATE IMMUNO- | Diagnostic Reagent Tech. | 1983-11-21 | Traditional | PDF ↗ |
| K832217 | VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD | Ventrex Laboratories, Inc. | 1983-09-20 | Traditional | PDF ↗ |
| K831554 | NEIN ALLERGEN DISC IN VAST VENTREX TEST | Ventrex Laboratories, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K831442 | PHADEBAS & PHADEZYM RAST ALLERGEN DISCS | Pharmacia, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K831091 | NEW ALLERGEN DISC -VAST VENTEX ALLERGY | Ventrex Laboratories, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K831045 | PHADEBAS & PHADEZYM RAST MIXED ALLERG | Pharmacia, Inc. | 1983-04-27 | Traditional | PDF ↗ |
| K823592 | PHADEBAS & PHADEZYM RAST TEST ALLERG | Pharmacia, Inc. | 1983-03-24 | Traditional | PDF ↗ |
| K830155 | PHADEBAS & PHADEZYM RAST ALLERGEN DISCS | Pharmacia, Inc. | 1983-03-10 | Traditional | PDF ↗ |
| K823593 | INHALANT PROFILE-ALLERGEN-SPECIFIC IGE | Mast Immunosystems | 1983-02-25 | Traditional | PDF ↗ |
| K830170 | RIASSIST RAST DATA REDUCTION/QUALITY | Ventrex Laboratories, Inc. | 1983-02-07 | Traditional | PDF ↗ |
| K830096 | PHADEBAS & PHADEZYME RAST ALLERGEN DISC | Pharmacia, Inc. | 1983-01-28 | Traditional | PDF ↗ |
| K823470 | ALLERCOAT ALLERGEN DISCS | Kallestad Laboratories, Inc. | 1982-12-15 | Traditional | PDF ↗ |
| K822141 | PHADEBAS RAST TEST | Pharmacia, Inc. | 1982-08-03 | Traditional | PDF ↗ |
| K821451 | VAST VENTREX ALLERGY SYSTEMS TESTS | Ventrex Laboratories, Inc. | 1982-06-23 | Traditional | PDF ↗ |
| K820029 | KALLESTAD RAST REAGENTS | Kallestad Laboratories, Inc. | 1982-04-06 | Traditional | PDF ↗ |
| K812414 | KALLESTAD 125I ANTISERUM TO HUMAN IGE | Kallestad Laboratories, Inc. | 1981-09-14 | Traditional | PDF ↗ |
| K810462 | PHADEZYM RAST TEST | Pharmacia, Inc. | 1981-03-11 | Traditional | PDF ↗ |
| K802556 | PHADEBAS RAST TEST | Pharmacia, Inc. | 1980-12-02 | Traditional | PDF ↗ |
| K771578 | PHADEBAS RAST PENICLLOYL G/V TEST | Pharmacia, Inc. | 1977-09-02 | Traditional | PDF ↗ |
Product code DHB · Class II · Immunology. Data: openFDA.