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Immunology

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

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RecordFirmDate
QM300 TRANSFERRIN ANTIBODY PACK (K873789)Kallestad Diag, A Div. of Erbamont, Inc.1987-10-07
RED TOP ALLERGEN DISC (K873486)Incstar Corp.1987-10-07
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT (K873676)Incstar Corp.1987-10-07
RRT SHORT RAGWEED TEST KIT (K873406)Incstar Corp.1987-09-23
TURBOX (K873401)Unipath , Ltd.1987-09-23
RRT SYSTEM LASER REFLECTOMETER ANALYZER (K873407)Incstar Corp.1987-09-23
ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS (K873249)Cytotech, Inc.1987-09-22
MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE (K872230)Intermedics, Inc.1987-09-15
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 (K872801)Diagnostic Products Corp.1987-09-10
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 (K872913)Diagnostic Products Corp.1987-09-10
THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (K872085)Immunodiagnostics, Ltd.1987-09-01
ULTRASCAN IGE ASSAY KIT (K872968)Specialty Medical Industries, Inc.1987-08-28
DELFIA(TM) FERRITIN KIT (K872955)Lkb Instruments, Inc.1987-08-21
BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM (K872845)Bion Ent., Ltd.1987-08-17
ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) (K871994)Behring Diagnostics, Inc.1987-08-12
TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 (K872834)Helena Laboratories1987-08-12
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT (K872800)Abbott Laboratories1987-08-12
IMMUNO/SLE (K872910)Immunostics Co., Inc.1987-08-12
QM300 C4 ANTIBODY PACK (K872599)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-23
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY (K872426)Cytotech, Inc.1987-07-23
QM300 HAPTOGLOBIN ANTIBODY PACK (K872717)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-21
ANTI-DNP MICROASSAY (K872560)Diamedix Corp.1987-07-21
STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY (K871972)American Dade1987-07-21
ALTERNARIA TENUIS ALLERGEN DISC (K871684)Incstar Corp.1987-07-16
SWEET VERNAL ALLERGEN DISC (K871723)Incstar Corp.1987-07-13
KALLESTAD QM300 IGM ANTIBODY PACK (K872237)Kallestad Diag, A Div. of Erbamont, Inc.1987-07-09
VENTRESCREEN (TM) MONO (K872032)Ventrex Laboratories, Inc.1987-06-29
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078)Solomon Park Research Laboratories1987-06-18
TINA-QUANT [A] CRP (K871895)Boehringer Mannheim Corp.1987-06-15
TINA-QUANT [A] TRANSFERRIN (K871896)Boehringer Mannheim Corp.1987-06-15
RAICHEM(TM) SPIA(TM) APO B REAGENTS (K872080)Reagents Applications, Inc.1987-06-15
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL (K871940)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
DELFIA(TM) HIGE KIT (K871599)Lkb Instruments, Inc.1987-06-12
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM (K871489)Diagnostic Systems Laboratories, Inc.1987-06-12
QM300 C3 ANTIBODY PACK (K871939)Kallestad Diag, A Div. of Erbamont, Inc.1987-06-12
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT (K871801)Cytotech, Inc.1987-06-09
TRI-LEVEL LIGAND CONTROL (K864877)Ciba Corning Diagnostics Corp.1987-05-21
PRECINORM(R) PROTEIN (K871027)Boehringer Mannheim Corp.1987-05-15
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT (K871193)Cronus1987-05-15
QM2/QM300 BUFFER AND DILUENT PACK (K871343)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
PRECIMAT(R) C3 (K871024)Boehringer Mannheim Corp.1987-05-15
PRECIMAT(R) TRANSFERRIN (K871022)Boehringer Mannheim Corp.1987-05-14
PRECIMAT(R) C4 (K871023)Boehringer Mannheim Corp.1987-05-14
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (K870903)Immunomedics, Inc.1987-05-14
WESTERN RAGWEED ALLERGEN DISC (K871660)Incstar Corp.1987-05-14
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST (K871196)Orion Diagnostica, Inc.1987-05-06
PRECIMAT(R) CRP (K871055)Boehringer Mannheim Corp.1987-05-06
IVT SOUTHWEST ALLERGY SCREEN (K870625)In Vitro Technologies, Inc.1987-05-01
TANGENT SYSTEM(TM) ANA PROFILE TEST KIT (K871144)Vitrotec Laboratories, Inc.1987-04-29
TITAN GEL IMMUNOFIX CONTROLS (K871498)Helena Laboratories1987-04-29
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. (K871331)Ventrex Laboratories, Inc.1987-04-28
QM300 IGG ANTIBODY PACK (K871340)Kallestad Diag, A Div. of Erbamont, Inc.1987-04-22
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS (K871352)Helena Laboratories1987-04-22
DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY (K871346)Dako Corp.1987-04-21
I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT (K871194)Cronus1987-04-20
DUAL SUBSTRATE ANA (K871395)Val Tech Diagnostics, Inc.1987-04-20
TOTAL IGE MASTICK (K870966)Mast Immunosystems1987-04-14
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. (K870009)Ventrex Laboratories, Inc.1987-04-14
RF MICROASSAY (K871041)Diamedix Corp.1987-03-31
SANASSAY IC TEST (K860996)Scientific Sales Intl., Inc.1987-03-30
DS-DNA EIA DIAGNOSTIC KIT (K870453)Biohytech International, Inc.1987-03-24
TINA-QUANT(R) (A) C4 (K870931)Boehringer Mannheim Corp.1987-03-24
TINA-QUANT(R) (A) C3 (K870930)Boehringer Mannheim Corp.1987-03-24
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY (K870624)Ventrex Laboratories, Inc.1987-03-24
RNP EIA DIAGNOSTIC KIT (K870457)Biohytech International, Inc.1987-03-17
DNP EIA DIAGNOSTIC KIT (K870456)Biohytech International, Inc.1987-03-17
SM EIA DIAGNOSTIC KIT (K870455)Biohytech International, Inc.1987-03-17
SS-DNA EIA DIAGNOSTIC KIT (K870452)Biohytech International, Inc.1987-03-17
ALLERG*ENS ENZYME IMMUNOASSAY KIT (K864696)Dexall Biomedical Labs, Inc.1987-03-17
HISTONES EIA DIAGNOSTIC KIT (K870458)Biohytech International, Inc.1987-03-17
VISION(TM) CRP (K864131)Abbott Laboratories1987-03-16
EZ COMPLEMENT REAGENTS, 78N2212 (K870351)Diamedix Corp.1987-03-13
ANA TEST KIT (K864668)Val Tech Diagnostics, Inc.1987-03-12
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM (K870570)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
RAT LIVER NUCLEI TEST SYSTEM (K870732)Val Tech Diagnostics, Inc.1987-03-10
D. FARINAE ALLERGEN DISC (K870597)Incstar Corp.1987-03-04
SERA-TEK MICROSOMAL ANTIBODY TEST (K865053)Miles Laboratories, Inc.1987-02-18
CAT EPITHELIUM ALLERGEN DISC (K870264)Incstar Corp.1987-02-13
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO (K864512)Cooper Biomedical, Inc.1987-02-13
IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT (K863868)Cooper Biomedical, Inc.1987-02-13
ALLERGEN SPECIFIC IGG4 CONTROL SERA (K870153)3M Company1987-02-12
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST (K864104)3M Company1987-02-12
COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS (K870107)Diagnostic Products Corp.1987-02-10
ALLERGEN SPECIFIC CONTROLS (K870152)3M Company1987-02-06
SERA-TEK THYROGLOBULIN ANTIBODY TEST (K865020)Miles Laboratories, Inc.1987-02-02
BECKMAN EPSILON(TM) FERRITIN TEST KIT (K864437)Beckman Instruments, Inc.1987-01-16
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II (K865014)Bio-Rad1987-01-09
IC MICROASSAY (K864312)Diamedix Corp.1987-01-09
FLUORESCENCE CONCENTRATION ANALYZER (FCA) (K864699)Pandex Laboratories, Inc.1986-12-22
SPECIFIC IGE FAST(TM) TEST II (K863967)3M Company1986-12-22
ANTI-NDNA ANTIBODY TEST KIT (K864275)Cappel Diagnostics, Inc.1986-12-15
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (K863743)Immuno Nuclear Corp.1986-12-15
IL TEST 97573-15, PLASMINOGEN ASSAY (K864212)Instrumentation Laboratory CO1986-12-04
DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO (K864207)Gamma Biologicals, Inc.1986-12-03
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE (K864142)United Biotech, Inc.1986-12-03
IMMPULSE IGE ASSAY REAGENTS (K863327)Sclavo, Inc.1986-12-03
3M IGG4 FAST TEST PACKAGE (K863794)3M Company1986-12-03
RAPID SPECIFIC IGE PROCEDURE (K863394)Allertec, Inc.1986-12-03
SANTEST 1AP (K862087)Scientific Sales Intl., Inc.1986-12-03
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX (K864342)Eiken Chemical Co., Inc.1986-12-01
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