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 2 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K922538 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-07-27 | Traditional | PDF ↗ |
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | Ventrex Laboratories, Inc. | 1992-03-13 | Traditional | PDF ↗ |
| K913833 | VENTREX ALLERGEN DISC | Ventrex Laboratories, Inc. | 1992-02-21 | Traditional | PDF ↗ |
| K914850 | CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE | Mast Immunosystems | 1991-12-09 | Traditional | PDF ↗ |
| K913150 | ABBOTT MATRIX AERO PLUS SYSTEM | Abbott Laboratories | 1991-11-29 | Traditional | PDF ↗ |
| K912294 | ALLERGY INFORMATION MANAGER | Diagnostic Products Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K913212 | 3M IGE SINGLE POINT FAST TEST | Whittaker Bioproducts, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913892 | FASTTECH SYSTEM II | 3M Diagnostic Systems, Inc. | 1991-10-02 | Traditional | PDF ↗ |
| K911903 | ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA | Pharmacia, Inc. | 1991-08-12 | Traditional | PDF ↗ |
| K912582 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1991-07-31 | Traditional | PDF ↗ |
| K894227 | ALLERGEN MODULES FOR ALASTAT TM | Diagnostic Products Corp. | 1991-04-17 | Traditional | PDF ↗ |
| K910292 | MAST CLA ALLERGY SYSTEM | Mast Immunosystems | 1991-04-05 | Traditional | PDF ↗ |
| K905054 | CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER | Ciba Corning Diagnostics Corp. | 1991-03-22 | Traditional | PDF ↗ |
| K910517 | CAP SYSTEM RAST ASM/RIA AND ASM/FEIA | Pharmacia, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | 1991-02-07 | Traditional | PDF ↗ |
| K910075 | SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE | Diagnostic Products Corp. | 1991-01-30 | Traditional | PDF ↗ |
| K905162 | QUIDEL TOTAL IGE POSITIVE CONTROL SERUM | Quidel Corp. | 1991-01-14 | Traditional | PDF ↗ |
| K905176 | POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN | Quidel Corp. | 1990-12-13 | Traditional | PDF ↗ |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904661 | IVT RAST TRACER | In Vitro Technologies, Inc. | 1990-11-29 | Traditional | PDF ↗ |
| K903637 | ALRGN SET | Ciba Corning Diagnostics Corp. | 1990-11-21 | Traditional | PDF ↗ |
| K903742 | ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE | Diagnostic Products Corp. | 1990-10-15 | Traditional | PDF ↗ |
| K902576 | ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA | Diagnostic Products Corp. | 1990-09-04 | Traditional | PDF ↗ |
| K894190 | PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA | Pharmacia, Inc. | 1990-01-22 | Traditional | PDF ↗ |
| K897145 | 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) | 3M Company | 1990-01-10 | Traditional | PDF ↗ |
| K896902 | ENZYMUN TEST R IGE | Boehringer Mannheim Corp. | 1990-01-10 | Traditional | PDF ↗ |
| K896852 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | 1989-12-18 | Traditional | PDF ↗ |
| K896694 | VENTREZYME VAST SPECIFIC IGE ASSAY | Ventrex Laboratories, Inc. | 1989-12-08 | Traditional | PDF ↗ |
| K896592 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY | Ciba Corning Diagnostics Corp. | 1989-12-04 | Traditional | PDF ↗ |
| K894253 | QUIDEL FOOD ALLERGEN SCREEN | Quidel Corp. | 1989-07-28 | Traditional | PDF ↗ |
| K893132 | PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC | Pharmacia, Inc. | 1989-06-02 | Traditional | PDF ↗ |
| K891135 | PHADIATOP PAEDIATRIC RIA AND EIA | Pharmacia, Inc. | 1989-05-09 | Traditional | PDF ↗ |
| K892409 | QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN | Quidel Corp. | 1989-05-04 | Traditional | PDF ↗ |
| K884501 | QUIDEL FOOD ALLERGY SCREEN | Quidel Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K885269 | ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS | Dexall Biomedical Labs, Inc. | 1989-02-07 | Traditional | PDF ↗ |
| K884883 | 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) | Diagnostic Products Corp. | 1989-01-23 | Traditional | PDF ↗ |
| K884923 | MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) | Diagnostic Products Corp. | 1989-01-11 | Traditional | PDF ↗ |
| K885065 | IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) | 3M Company | 1989-01-04 | Traditional | PDF ↗ |
| K883537 | QM300 CONTROL E | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-11-04 | Traditional | PDF ↗ |
| K884185 | CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-10-27 | Traditional | PDF ↗ |
| K883371 | MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) | 3M Company | 1988-10-27 | Traditional | PDF ↗ |
| K883666 | QUIDEL ALLERGY SCREEN | Quidel Corp. | 1988-10-18 | Traditional | PDF ↗ |
| K883616 | SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) | Diagnostic Products Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K883273 | DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) | 3M Company | 1988-09-07 | Traditional | PDF ↗ |
| K881899 | SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. | Diagnostic Products Corp. | 1988-08-10 | Traditional | PDF ↗ |
| K875110 | HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC | Incstar Corp. | 1988-06-14 | Traditional | PDF ↗ |
| K880899 | PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA | Pharmacia, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K880168 | INCSTAR'S BIRCH ALLERGEN DISC | Incstar Corp. | 1988-05-11 | Traditional | PDF ↗ |
| K880221 | INCSTAR'S PIGWEED ALLERGEN DISC | Incstar Corp. | 1988-05-11 | Traditional | PDF ↗ |
| K874540 | MARSH ELDER ALLERGEN DISC | Incstar Corp. | 1988-05-11 | Traditional | PDF ↗ |
| K874883 | WALNUT ALLERGEN DISC | Incstar Corp. | 1988-05-11 | Traditional | PDF ↗ |
| K880187 | INCSTAR'S DANDELION ALLERGEN DISC | Incstar Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K875163 | GOLDENROD ALLERGEN DISC | Incstar Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K875244 | ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM | Diagnostic Products Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K880160 | DPC'S ALLERGEN-SPECIFIC IGE SYSTEM | Diagnostic Products Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K880415 | MESQUITE ALLERGEN DISC | Incstar Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K880567 | WHITE ASH ALLERGEN DISC | Incstar Corp. | 1988-04-21 | Traditional | PDF ↗ |
| K875329 | IVT CENTRAL ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-04-07 | Traditional | PDF ↗ |
| K874717 | QUIDEL ALLERGY SCREEN | Quidel Corp. | 1988-04-06 | Traditional | PDF ↗ |
| K880547 | VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY | Ventrex Laboratories, Inc. | 1988-03-25 | Traditional | PDF ↗ |
| K875328 | IVT WESTERN ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-03-23 | Traditional | PDF ↗ |
| K875168 | QUIDEL TOTAL IGE TEST | Quidel Corp. | 1988-03-18 | Traditional | PDF ↗ |
| K880003 | ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST | Em Diagnostic Systems, Inc. | 1988-03-11 | Traditional | PDF ↗ |
| K880001 | MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 | 3M Company | 1988-02-25 | Traditional | PDF ↗ |
| K875125 | PROGENE(TM) IGE TEST | Progene Corp. | 1988-02-25 | Traditional | PDF ↗ |
| K880002 | MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) | 3M Company | 1988-02-17 | Traditional | PDF ↗ |
| K874802 | FLIPSCREEN QAT | Alerchek, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K875274 | TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) | Incstar Corp. | 1988-02-17 | Traditional | PDF ↗ |
| K875066 | ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT | Dexall Biomedical Labs, Inc. | 1988-01-29 | Traditional | PDF ↗ |
| K874169 | IVT NORTHEAST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-01-11 | Traditional | PDF ↗ |
| K874168 | IVT SOUTHEAST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1988-01-11 | Traditional | PDF ↗ |
| K874446 | MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) | 3M Company | 1987-12-30 | Traditional | PDF ↗ |
| K874281 | MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT | Medix Biotech, Inc. | 1987-12-18 | Traditional | PDF ↗ |
| K874440 | LIVE OAK ALLERGEN DISC | Incstar Corp. | 1987-11-25 | Traditional | PDF ↗ |
| K874149 | FALSE RAGWEED ALLERGEN DISC | Incstar Corp. | 1987-11-04 | Traditional | PDF ↗ |
| K873969 | GIANT RAGWEED ALLERGEN DISC | Incstar Corp. | 1987-11-04 | Traditional | PDF ↗ |
| K874150 | JOHNSON GRASS ALLERGEN DISC | Incstar Corp. | 1987-11-04 | Traditional | PDF ↗ |
| K873998 | TOTAL IGE FAST (TM) TEST PACKAGE | 3M Company | 1987-11-04 | Traditional | PDF ↗ |
| K873814 | IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST | Incstar Corp. | 1987-10-20 | Traditional | PDF ↗ |
| K873770 | BERMUDA GRASS ALLERGEN DISC | Incstar Corp. | 1987-10-20 | Traditional | PDF ↗ |
| K873112 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC | Pharmacia, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K872946 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC | Pharmacia, Inc. | 1987-10-20 | Traditional | PDF ↗ |
| K873193 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS | Pharmacia, Inc. | 1987-10-08 | Traditional | PDF ↗ |
| K873648 | BAHIA ALLERGEN DISC | Incstar Corp. | 1987-10-08 | Traditional | PDF ↗ |
| K873486 | RED TOP ALLERGEN DISC | Incstar Corp. | 1987-10-07 | Traditional | PDF ↗ |
| K873676 | IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT | Incstar Corp. | 1987-10-07 | Traditional | PDF ↗ |
| K872280 | MODIFIED PHADEBAS RAST/PHADEZYM RAST | Pharmacia, Inc. | 1987-10-07 | Traditional | PDF ↗ |
| K873406 | RRT SHORT RAGWEED TEST KIT | Incstar Corp. | 1987-09-23 | Traditional | PDF ↗ |
| K871684 | ALTERNARIA TENUIS ALLERGEN DISC | Incstar Corp. | 1987-07-16 | Traditional | PDF ↗ |
| K871723 | SWEET VERNAL ALLERGEN DISC | Incstar Corp. | 1987-07-13 | Traditional | PDF ↗ |
| K871599 | DELFIA(TM) HIGE KIT | Lkb Instruments, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K871660 | WESTERN RAGWEED ALLERGEN DISC | Incstar Corp. | 1987-05-14 | Traditional | PDF ↗ |
| K870625 | IVT SOUTHWEST ALLERGY SCREEN | In Vitro Technologies, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K871331 | VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. | Ventrex Laboratories, Inc. | 1987-04-28 | Traditional | PDF ↗ |
| K870009 | VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. | Ventrex Laboratories, Inc. | 1987-04-14 | Traditional | PDF ↗ |
| K870966 | TOTAL IGE MASTICK | Mast Immunosystems | 1987-04-14 | Traditional | PDF ↗ |
| K870624 | VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY | Ventrex Laboratories, Inc. | 1987-03-24 | Traditional | PDF ↗ |
| K864696 | ALLERG*ENS ENZYME IMMUNOASSAY KIT | Dexall Biomedical Labs, Inc. | 1987-03-17 | Traditional | PDF ↗ |
| K870597 | D. FARINAE ALLERGEN DISC | Incstar Corp. | 1987-03-04 | Traditional | PDF ↗ |
| K870264 | CAT EPITHELIUM ALLERGEN DISC | Incstar Corp. | 1987-02-13 | Traditional | PDF ↗ |
Product code DHB · Class II · Immunology. Data: openFDA.