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 |
|---|---|---|---|
| May 11, 1988 | K874540 | MARSH ELDER ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880567 | WHITE ASH ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880415 | MESQUITE ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880187 | INCSTAR'S DANDELION ALLERGEN DISC Incstar Corp. | DHB |
| Apr 21, 1988 | K880160 | DPC'S ALLERGEN-SPECIFIC IGE SYSTEM Diagnostic Products Corp. | DHB |
| Apr 21, 1988 | K875244 | ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM Diagnostic Products Corp. | DHB |
| Apr 21, 1988 | K875163 | GOLDENROD ALLERGEN DISC Incstar Corp. | DHB |
| Apr 7, 1988 | K875329 | IVT CENTRAL ALLERGY SCREEN In Vitro Technologies, Inc. | DHB |
| Apr 6, 1988 | K874717 | QUIDEL ALLERGY SCREEN Quidel Corp. | DHB |
| Mar 25, 1988 | K880547 | VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY Ventrex Laboratories, Inc. | DHB |
| Mar 23, 1988 | K875328 | IVT WESTERN ALLERGY SCREEN In Vitro Technologies, Inc. | DHB |
| Mar 18, 1988 | K875168 | QUIDEL TOTAL IGE TEST Quidel Corp. | DHB |
| Mar 11, 1988 | K880003 | ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST Em Diagnostic Systems, Inc. | DHB |
| Feb 25, 1988 | K880001 | MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 3M Company | DHB |
| Feb 25, 1988 | K875125 | PROGENE(TM) IGE TEST Progene Corp. | DHB |
| Feb 17, 1988 | K880002 | MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) 3M Company | DHB |
| Feb 17, 1988 | K875274 | TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) Incstar Corp. | DHB |
| Feb 17, 1988 | K874802 | FLIPSCREEN QAT Alerchek, Inc. | DHB |
| Jan 29, 1988 | K875066 | ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT Dexall Biomedical Labs, Inc. | DHB |
| Jan 11, 1988 | K874169 | IVT NORTHEAST ALLERGY SCREEN In Vitro Technologies, Inc. | DHB |
| Jan 11, 1988 | K874168 | IVT SOUTHEAST ALLERGY SCREEN In Vitro Technologies, Inc. | DHB |
| Dec 30, 1987 | K874446 | MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) 3M Company | DHB |
| Dec 18, 1987 | K874281 | MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT Medix Biotech, Inc. | DHB |
| Nov 25, 1987 | K874440 | LIVE OAK ALLERGEN DISC Incstar Corp. | DHB |
| Nov 4, 1987 | K874150 | JOHNSON GRASS ALLERGEN DISC Incstar Corp. | DHB |
| Nov 4, 1987 | K874149 | FALSE RAGWEED ALLERGEN DISC Incstar Corp. | DHB |
| Nov 4, 1987 | K873998 | TOTAL IGE FAST (TM) TEST PACKAGE 3M Company | DHB |
| Nov 4, 1987 | K873969 | GIANT RAGWEED ALLERGEN DISC Incstar Corp. | DHB |
| Oct 20, 1987 | K873814 | IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST Incstar Corp. | DHB |
| Oct 20, 1987 | K873770 | BERMUDA GRASS ALLERGEN DISC Incstar Corp. | DHB |
| Oct 20, 1987 | K873112 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC Pharmacia, Inc. | DHB |
| Oct 20, 1987 | K872946 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC Pharmacia, Inc. | DHB |
| Oct 8, 1987 | K873648 | BAHIA ALLERGEN DISC Incstar Corp. | DHB |
| Oct 8, 1987 | K873193 | PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. | DHB |
| Oct 7, 1987 | K873676 | IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT Incstar Corp. | DHB |
| Oct 7, 1987 | K873486 | RED TOP ALLERGEN DISC Incstar Corp. | DHB |
| Oct 7, 1987 | K872280 | MODIFIED PHADEBAS RAST/PHADEZYM RAST Pharmacia, Inc. | DHB |
| Sep 23, 1987 | K873406 | RRT SHORT RAGWEED TEST KIT Incstar Corp. | DHB |
| Jul 16, 1987 | K871684 | ALTERNARIA TENUIS ALLERGEN DISC Incstar Corp. | DHB |
| Jul 13, 1987 | K871723 | SWEET VERNAL ALLERGEN DISC Incstar Corp. | DHB |
| Jun 12, 1987 | K871599 | DELFIA(TM) HIGE KIT Lkb Instruments, Inc. | DHB |
| May 14, 1987 | K871660 | WESTERN RAGWEED ALLERGEN DISC Incstar Corp. | DHB |
| May 1, 1987 | K870625 | IVT SOUTHWEST ALLERGY SCREEN In Vitro Technologies, Inc. | DHB |
| Apr 28, 1987 | K871331 | VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. Ventrex Laboratories, Inc. | DHB |
| Apr 14, 1987 | K870966 | TOTAL IGE MASTICK Mast Immunosystems | DHB |
| Apr 14, 1987 | K870009 | VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. Ventrex Laboratories, Inc. | DHB |
| Mar 24, 1987 | K870624 | VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. | DHB |
| Mar 17, 1987 | K864696 | ALLERG*ENS ENZYME IMMUNOASSAY KIT Dexall Biomedical Labs, Inc. | DHB |
| Mar 4, 1987 | K870597 | D. FARINAE ALLERGEN DISC Incstar Corp. | DHB |
| Feb 13, 1987 | K870264 | CAT EPITHELIUM ALLERGEN DISC Incstar Corp. | DHB |
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