meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
41
Latest Decision
1987-10-20

Clearances · page 27 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K873112 PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC Pharmacia, Inc. DHB Class II 1987-10-20
K873861 ALBUMIN IN URINE Unipath , Ltd. DCF Class II 1987-10-13
K873867 TRANSFERRIN Unipath , Ltd. DDG Class II 1987-10-13
K873865 CRP Unipath , Ltd. DCK Class II 1987-10-13
K873870 IMMUNOGLOBULINS G Unipath , Ltd. DEW Class II 1987-10-13
K873871 IMMUNOGLOBULINS M Unipath , Ltd. DFT Class II 1987-10-13
K873869 IMMUNOGLOBULINS A Unipath , Ltd. CZP Class II 1987-10-13
K873193 PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1987-10-08
K873648 BAHIA ALLERGEN DISC Incstar Corp. DHB Class II 1987-10-08
K873789 QM300 TRANSFERRIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DDG Class II 1987-10-07
K872280 MODIFIED PHADEBAS RAST/PHADEZYM RAST Pharmacia, Inc. DHB Class II 1987-10-07
K873573 CIBA CORNING MAGIC LITE FERRITIN Ciba Corning Diagnostics Corp. DBF Class II 1987-10-07
K873676 IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT Incstar Corp. DHB Class II 1987-10-07
K873486 RED TOP ALLERGEN DISC Incstar Corp. DHB Class II 1987-10-07
K873407 RRT SYSTEM LASER REFLECTOMETER ANALYZER Incstar Corp. JZW Class I 1987-09-23
K873406 RRT SHORT RAGWEED TEST KIT Incstar Corp. DHB Class II 1987-09-23
K873401 TURBOX Unipath , Ltd. JZW Class I 1987-09-23
K873249 ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLS Cytotech, Inc. LKJ Class II 1987-09-22
K872230 MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE Intermedics, Inc. DBT Class I 1987-09-15
K872801 ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 Diagnostic Products Corp. DGO Class II 1987-09-10
K872913 ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 Diagnostic Products Corp. DGC Class II 1987-09-10
K872085 THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS Immunodiagnostics, Ltd. LSW Class II 1987-09-01
K872968 ULTRASCAN IGE ASSAY KIT Specialty Medical Industries, Inc. DGC Class II 1987-08-28
K872955 DELFIA(TM) FERRITIN KIT Lkb Instruments, Inc. JMG Class II 1987-08-21
K872845 BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM Bion Ent., Ltd. DHN Class II 1987-08-17
K872834 TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 Helena Laboratories CZJ Class II 1987-08-12
K871994 ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) Behring Diagnostics, Inc. LLL Class II 1987-08-12
K872910 IMMUNO/SLE Immunostics Co., Inc. DHC Class II 1987-08-12
K872800 TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT Abbott Laboratories DEW Class II 1987-08-12
K872599 QM300 C4 ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DBI Class II 1987-07-23
K872426 CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY Cytotech, Inc. DBA Class II 1987-07-23
K872717 QM300 HAPTOGLOBIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DAD Class II 1987-07-21
K872560 ANTI-DNP MICROASSAY Diamedix Corp. DHN Class II 1987-07-21
K871972 STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY American Dade DGE Class II 1987-07-21
K871684 ALTERNARIA TENUIS ALLERGEN DISC Incstar Corp. DHB Class II 1987-07-16
K871723 SWEET VERNAL ALLERGEN DISC Incstar Corp. DHB Class II 1987-07-13
K872237 KALLESTAD QM300 IGM ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DFT Class II 1987-07-09
K872032 VENTRESCREEN (TM) MONO Ventrex Laboratories, Inc. KTN Class II 1987-06-29
K872078 QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL Solomon Park Research Laboratories DER Class II 1987-06-18
K872080 RAICHEM(TM) SPIA(TM) APO B REAGENTS Reagents Applications, Inc. DFC Class II 1987-06-15
K871895 TINA-QUANT [A] CRP Boehringer Mannheim Corp. DCK Class II 1987-06-15
K871896 TINA-QUANT [A] TRANSFERRIN Boehringer Mannheim Corp. DDG Class II 1987-06-15
K871489 DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM Diagnostic Systems Laboratories, Inc. DBF Class II 1987-06-12
K871939 QM300 C3 ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. CZW Class II 1987-06-12
K871940 QM300 IGA, ANTIGEN, ANTISERUM, CONTROL Kallestad Diag, A Div. of Erbamont, Inc. CZP Class II 1987-06-12
K871599 DELFIA(TM) HIGE KIT Lkb Instruments, Inc. DHB Class II 1987-06-12
K871801 CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT Cytotech, Inc. DHN Class II 1987-06-09
K864877 TRI-LEVEL LIGAND CONTROL Ciba Corning Diagnostics Corp. DHX Class II 1987-05-21
K871193 I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT Cronus JZO Class II 1987-05-15
K871024 PRECIMAT(R) C3 Boehringer Mannheim Corp. CZW Class II 1987-05-15
K871027 PRECINORM(R) PROTEIN Boehringer Mannheim Corp. DAF Class II 1987-05-15
K871343 QM2/QM300 BUFFER AND DILUENT PACK Kallestad Diag, A Div. of Erbamont, Inc. CFN Class II 1987-05-15
K871023 PRECIMAT(R) C4 Boehringer Mannheim Corp. DBI Class II 1987-05-14
K870903 IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM Immunomedics, Inc. LRM Class II 1987-05-14
K871660 WESTERN RAGWEED ALLERGEN DISC Incstar Corp. DHB Class II 1987-05-14
K871022 PRECIMAT(R) TRANSFERRIN Boehringer Mannheim Corp. DDG Class II 1987-05-14
K871055 PRECIMAT(R) CRP Boehringer Mannheim Corp. DCK Class II 1987-05-06
K871196 RHEUMA-CHECK ENZYME IMMUNOASSAY TEST Orion Diagnostica, Inc. DHR Class II 1987-05-06
K870625 IVT SOUTHWEST ALLERGY SCREEN In Vitro Technologies, Inc. DHB Class II 1987-05-01
K871498 TITAN GEL IMMUNOFIX CONTROLS Helena Laboratories DFT Class II 1987-04-29
K871144 TANGENT SYSTEM(TM) ANA PROFILE TEST KIT Vitrotec Laboratories, Inc. DHN Class II 1987-04-29
K871331 VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU. Ventrex Laboratories, Inc. DHB Class II 1987-04-28
K871340 QM300 IGG ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DEW Class II 1987-04-22
K871352 PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS Helena Laboratories DEW Class II 1987-04-22
K871346 DAKO ITA(TM) SYSTEM, FOR IMMUNOTURBIDIMETRIC ASSAY Dako Corp. CZW Class II 1987-04-21
K871395 DUAL SUBSTRATE ANA Val Tech Diagnostics, Inc. DHN Class II 1987-04-20
K871194 I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT Cronus DBL Class II 1987-04-20
K870966 TOTAL IGE MASTICK Mast Immunosystems DHB Class II 1987-04-14
K870009 VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM. Ventrex Laboratories, Inc. DHB Class II 1987-04-14
K871041 RF MICROASSAY Diamedix Corp. DHR Class II 1987-03-31
K860996 SANASSAY IC TEST Scientific Sales Intl., Inc. DAK Class II 1987-03-30
K870930 TINA-QUANT(R) (A) C3 Boehringer Mannheim Corp. CZM Class II 1987-03-24
K870624 VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. DHB Class II 1987-03-24
K870931 TINA-QUANT(R) (A) C4 Boehringer Mannheim Corp. DBI Class II 1987-03-24
K870453 DS-DNA EIA DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1987-03-24
K870458 HISTONES EIA DIAGNOSTIC KIT Biohytech International, Inc. DHN Class II 1987-03-17
K864696 ALLERG*ENS ENZYME IMMUNOASSAY KIT Dexall Biomedical Labs, Inc. DHB Class II 1987-03-17
K870455 SM EIA DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1987-03-17
K870452 SS-DNA EIA DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1987-03-17
K870457 RNP EIA DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1987-03-17
K870456 DNP EIA DIAGNOSTIC KIT Biohytech International, Inc. LJM Class II 1987-03-17
K864131 VISION(TM) CRP Abbott Laboratories DCK Class II 1987-03-16
K870351 EZ COMPLEMENT REAGENTS, 78N2212 Diamedix Corp. DHL Class I 1987-03-13
K870570 FERRITIN MAB SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic DBF Class II 1987-03-12
K864668 ANA TEST KIT Val Tech Diagnostics, Inc. LKJ Class II 1987-03-12
K870732 RAT LIVER NUCLEI TEST SYSTEM Val Tech Diagnostics, Inc. DHN Class II 1987-03-10
K870597 D. FARINAE ALLERGEN DISC Incstar Corp. DHB Class II 1987-03-04
K865053 SERA-TEK MICROSOMAL ANTIBODY TEST Miles Laboratories, Inc. JZO Class II 1987-02-18
K863868 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT Cooper Biomedical, Inc. DFF Class II 1987-02-13
K864512 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO Cooper Biomedical, Inc. DAD Class II 1987-02-13
K870264 CAT EPITHELIUM ALLERGEN DISC Incstar Corp. DHB Class II 1987-02-13
K864104 ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST 3M Company DHB Class II 1987-02-12
K870153 ALLERGEN SPECIFIC IGG4 CONTROL SERA 3M Company DHB Class II 1987-02-12
K870107 COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS Diagnostic Products Corp. DBF Class II 1987-02-10
K870152 ALLERGEN SPECIFIC CONTROLS 3M Company DHB Class II 1987-02-06
K865020 SERA-TEK THYROGLOBULIN ANTIBODY TEST Miles Laboratories, Inc. DDC Class II 1987-02-02
K864437 BECKMAN EPSILON(TM) FERRITIN TEST KIT Beckman Instruments, Inc. DBF Class II 1987-01-16
K864312 IC MICROASSAY Diamedix Corp. DAK Class II 1987-01-09
K865014 LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II Bio-Rad DGR Class I 1987-01-09
K863967 SPECIFIC IGE FAST(TM) TEST II 3M Company DHB Class II 1986-12-22

3,548 clearances in the Immunology panel. Data: openFDA.