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Immunology

3,537 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
EPSILON IGE TEST KIT (K831987)Beckman Instruments, Inc.1983-10-14
ABBOTT IGE EIA (K832360)Abbott Laboratories1983-10-14
FIAX IGG TEST (K832821)Intl. Diagnostic Technology1983-10-14
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD (K832217)Ventrex Laboratories, Inc.1983-09-20
ALLERGEN CONTROL INHALENT (K832218)Ventrex Laboratories, Inc.1983-09-20
ANA MICROZYME TEST SYS #1610 (K832675)Clinical Sciences, Inc.1983-09-12
IDT ANA STIQ ASSAY (K832383)Intl. Diagnostic Technology1983-08-31
FIAX CRP TEST KIT (K832054)Intl. Diagnostic Technology1983-08-26
ALLERGENETICS FLUORO-FAST READER (K831870)Axonics, Inc.1983-08-12
ANTI-N DNA ANTIBODY TEST KIT (K832031)Breit Laboratories, Inc.1983-08-11
REVOLUTION RADIAL IMMUNODIFFUSION PLATE (K831811)Calbiochem-Behring Corp.1983-07-28
DNA FLOR (K831408)Medastat Scientific Corp.1983-07-28
RADIAL IMMUNO-TEST FOR HUMAN FACTOR B (K831959)Kent Laboratories, Inc.1983-07-19
RABBIT ANTISERUM TO HUMAN C4 (K831906)Dako Corp.1983-07-19
RADIAL IMMUNO-TEST FOR HUMAN C-REACTI (K831958)Kent Laboratories, Inc.1983-07-19
FLUORESCEIN CONJUGATED IMMUNOGLOBULIN (K831903)Dako Corp.1983-07-19
RABBIT ANTISERUM TO HUMAN IGM (K831907)Dako Corp.1983-07-19
RABBIT ANTISERUM TO HUMAN KAPPA LIGHT (K831904)Dako Corp.1983-07-19
TEST FOR HUMAN ALPHA ONE ACID GLYCO- (K831960)Kent Laboratories, Inc.1983-07-19
ANTI-ENA TEST (K831292)Meloy Laboratories, Inc.1983-07-18
DETERM. SIZE 72 RADIAL-HUMAN IGD (K831956)Kent Laboratories, Inc.1983-07-18
FLUORESCEIN CONJUGATED IMMUNOGLOBIN- (K831902)Dako Corp.1983-07-18
LEAP RHEUMATOID FACTOR TEST KIT (K831941)Cooper Diagnostics, Inc.1983-07-18
DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB (K831957)Kent Laboratories, Inc.1983-07-18
RABBIT ANTISERUM TO HUMAN IGA (K831909)Dako Corp.1983-07-18
RABBITT ANTISERUM TO HUMAN C3C (K831905)Dako Corp.1983-07-18
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- (K831774)Diagnostic Reagent Tech.1983-07-18
ANTINUCLEAR ANTIBODY TEST KIT (K831927)Breit Laboratories, Inc.1983-07-18
RABBIT ANTISERUM TO HUMAN IGG (K831908)Dako Corp.1983-07-18
TITAN GE/IEPLATE (K831603)Helena Laboratories1983-07-07
SERO/TEX RED CELL RF TEST (K831597)Texas Immunology, Inc.1983-06-30
FIAX IGA TEST KIT (K831607)Intl. Diagnostic Technology1983-06-22
FIAX IGM TEST KIT (K831608)Intl. Diagnostic Technology1983-06-22
FIAX IGG TEST KIT (K831609)Intl. Diagnostic Technology1983-06-17
AUTOANTIBODY SCREEN TEST SYSTEM (K831358)Zeus Scientific, Inc.1983-06-15
RADIAL IMMUNODIFFUSION PLATES (K830911)Biocell Laboratories, Inc.1983-06-10
ANA-CHECK (K831463)Diagnostic Technology, Inc.1983-06-08
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS (K831442)Pharmacia, Inc.1983-06-08
NEIN ALLERGEN DISC IN VAST VENTREX TEST (K831554)Ventrex Laboratories, Inc.1983-06-08
CRP-CHECK (K831465)Diagnostic Technology, Inc.1983-06-08
RA-CHECK (K831467)Diagnostic Technology, Inc.1983-06-08
VENTRE/ZYME IGE KIT (K831485)Ventrex Laboratories, Inc.1983-06-02
IP SPECIFIC G (K830005)Diagnostic Reagent Tech.1983-06-02
ALLERCOAT ALLERGEN DISCS (K831326)Kallestad Laboratories, Inc.1983-06-02
IGE RADIOIMMUNOASSAY KIT (K831377)American Diagnostic Corp.1983-06-02
TESTCORP CRP (K831362)Catheter Technology Corp.1983-05-27
TESTCORP RA (K831364)Myo-Tronics Research, Inc.1983-05-27
IGE-QUANT DIAGNOSTIC TEST KIT (K831208)Leeco Diagnostics, Inc.1983-05-09
PREALBUMIN ENZYME IMMUNOASSAY (K821135)Abbott Laboratories1983-05-05
DIAGNON FERRITIN 125 I RIA KIT (K830580)Iagnon Corp.1983-05-05
MEDICA IIF-MULTIPLE ANTIBODY TEST KIT (K831100)Medical Diagnostics, Ca.1983-05-04
ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB (K831054)Immuno-Products Industries1983-04-27
PHADEBAS & PHADEZYM RAST MIXED ALLERG (K831045)Pharmacia, Inc.1983-04-27
NEW ALLERGEN DISC -VAST VENTEX ALLERGY (K831091)Ventrex Laboratories, Inc.1983-04-27
TIA-IGG REAGENT & CALIBRATOR SETS (K831101)Worthington Diagnostic Systems1983-04-27
TIA-IGM REAGENT & CALIBRATOR SETS (K831103)Worthington Diagnostic Systems1983-04-27
ENA TEST KIT SM & RNP AUTO ANTIBODY (K831036)Calbiochem-Behring Corp.1983-04-27
TIA-IGA REAGENT & CALIBRATOR SETS (K831102)Worthington Diagnostic Systems1983-04-27
NEW ALLERGEN DISCS FOR USE IN VAST VENT (K830817)Ventrex Laboratories, Inc.1983-04-27
RHEUMATOID FACTOR-RAPID CARD TEST #65114 (K830832)Emd Chemicals, Inc.1983-04-18
POLYSTYRENE MICROTITER PLATE IMMUNOSORB (K830653)Diagnostic Reagent Tech.1983-04-08
FIAX COMPLEMENT C4 TEST KIT (K830669)Intl. Diagnostic Technology1983-04-08
POLYSTYRENE MICROTITER PLATE IMMUNOSOR (K830495)Diagnostic Reagent Tech.1983-04-05
FIAX COMPLEMENT C3 TEST KIT (K830668)Intl. Diagnostic Technology1983-04-05
QUIK-SEP IGM ISOLATION SYSTEM (K830606)Isolab, Inc.1983-03-24
RA SCREENING TEST (K830611)Tago, Inc.1983-03-24
ANTI N DNA-HCP (K830652)Immuno-Products Industries1983-03-24
PHADEBAS & PHADEZYM RAST TEST ALLERG (K823592)Pharmacia, Inc.1983-03-24
TITAN IMMUNO-FIX (K830594)Helena Laboratories1983-03-24
CORNING FERRITIN 125I RADIOIMMUNOASSAY (K830591)Corning Medical & Scientific1983-03-24
RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E (K830357)Clinetics Corp.1983-03-17
MONO SCREENING TEST (K830531)Tago, Inc.1983-03-17
FERRITIN IMMUNORADIOMETRIC ASSAY KIT (K823829)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-03-11
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS (K830155)Pharmacia, Inc.1983-03-10
ROENTGENOGRAPHY SET (K830229)Mallinckrodt Critical Care1983-03-09
AFT SYSTEM III (K830214)Calbiochem-Behring Corp.1983-03-09
PARAGON IMMUNOELECTROPHORESIS REAGENT (K823884)Beckman Instruments, Inc.1983-03-07
DENSITOMETRIC INHALENT PROFILE SLLER (K830164)Mast Immunosystems1983-03-01
INHALANT PROFILE-ALLERGEN-SPECIFIC IGE (K823593)Mast Immunosystems1983-02-25
TANDEM-E -FER IMMUNOENZYMETRIC KIT (K823871)Hybritech, Inc.1983-02-25
RIASSIST RAST DATA REDUCTION/QUALITY (K830170)Ventrex Laboratories, Inc.1983-02-07
PHADEBAS & PHADEZYME RAST ALLERGEN DISC (K830096)Pharmacia, Inc.1983-01-28
TOTAL IGE-FAST TEST (K823494)Axonics, Inc.1983-01-14
PHADEZYM RAST ALLERGEN DISCS (K823842)Pharmacia, Inc.1983-01-12
PHADEBAS RAST ALLERGEN DISCS (K823841)Pharmacia, Inc.1983-01-12
COAT-A-COUNT MORPHINE KIT & COMPONENTS (K823680)Diagnostic Products Corp.1983-01-05
ANTI SERA TO HUMAN OROSCOMUCOID (K823765)Kent Laboratories, Inc.1982-12-30
IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM (K823567)Syva Co.1982-12-30
IMMUNOGLOBULIN CONTROL (K823566)Syva Co.1982-12-30
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY (K823507)Hybritech, Inc.1982-12-28
ALLERCOAT POSITIVE CONTROL SERUM (K823403)Kallestad Laboratories, Inc.1982-12-15
ALLERCOAT ALLERGEN DISCS (K823470)Kallestad Laboratories, Inc.1982-12-15
ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) (K822681)Amico Lab, Inc.1982-12-13
PRISMA C-REACTIVE PROTEIN ASSAY (K823416)Syva Co.1982-12-09
PRISMA-C-REACTIVE PROTEIN CALIBRATORS (K823417)Syva Co.1982-12-09
PRISMA C-REACTIVE PROTEIN CONTROLS (K823415)Syva Co.1982-12-09
AUTOPAK FERRITIN TEST DELIVERY SYS (K823275)Micromedic Systems1982-12-03
ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K (K822682)Amico Lab, Inc.1982-12-03
ANTISERUM TO HUMAN IGA (K822668)Amico Lab, Inc.1982-11-17
FITC ANTISERA TO HUMAN IGG (K822676)Amico Lab, Inc.1982-11-17
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