meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
48
Latest Decision
2011-12-02

Clearances · page 5 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K113143 IMMULISA SCI-70 ANTIBODY ELISA Immco Diagnostics, Inc. LLL Class II 2011-12-02
K112810 MULTI-ANALYTE DETECTION SYSTEMS Bio-Rad Laboratories NHX Class II 2011-10-26
K111414 QUANTA FLASH (TM) DGP SCREEN Inova Diagnostics, Inc. MST Class II 2011-10-20
K110345 SCANVIEW SYSTEM Applied Spectral Imaging NTH Class II 2011-10-19
K103757 IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT Grifols CFF Class II 2011-10-13
K102673 RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM Phadia US, Inc. DHR Class II 2011-09-30
K101185 NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY Iris Molecular Diagnostics OWM Class II 2011-09-20
K091960 VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 Abbott Molecular, Inc. OWK Class II 2011-08-29
K110296 AXIS-SHIELD ANTI-CCP Axis-Shield Diagnostics, Ltd. NHX Class II 2011-08-18
K110736 ADVIA CHEMISTRY FERRITIN (FRT) METHOD Siemens Healthcare Diagnostics, Inc. DBF Class II 2011-08-17
K100015 VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 Abbott Molecular, Inc. OVQ Class II 2011-08-09
K101572 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics DHB Class II 2011-08-01
K103676 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL Fujirebio Diagnostics,Inc. OIU Class II 2011-07-19
K101089 EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR Medica Corp. DCF Class II 2011-07-13
K102490 IGX PLEX CELIAC QUALITATIVE ASSAY Sqi Diagnostics Systems MVM Class II 2011-06-02
K101251 IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN Phadia AB DHB Class II 2011-05-27
K100831 CYFRA 21-1 EIA MODEL 211-10 Fujirebio Diagnostics,Inc. OVK Class II 2011-05-26
K100910 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 Siemens Medical Solutions Diagnostics DHB Class II 2011-05-11
K103557 DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET Diazyme Laboratories DCK Class II 2011-04-27
DEN110012 APTIMA TRICHOMONAS VAGINALIS ASSAY Gen-Probe Incorporated OUY Class II 2011-04-19
K100344 DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 Siemens Healthcare Diagnostics MOI Class II 2011-04-18
K100321 DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 Siemens Healthcare Diagnostics LTK Class II 2011-04-12
K100375 DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 Siemens Healthcare Diagnostics, Inc. NIG Class II 2011-04-06
K093987 IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 Siemens Healthcare Diagnostics, Inc. DHB Class II 2011-03-28
K101644 QUANTA FLASH H-TTG IGG Inova Diagnostics, Inc. MVM Class II 2011-03-23
K102964 EU-TTG IGA AND EU-TTG IGG Grifols USA, Inc. MVM Class II 2011-03-07
K100464 UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION Wako Chemicals USA, Inc. NSF Class II 2011-02-23
K101454 MAMMAPRINT Agendia NYI Class II 2011-01-28
K101853 PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 Diadexus, Inc. NOE Class II 2011-01-03
K103502 CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 Veridex, LLC NQI Class II 2010-12-21
K100999 IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01 Phadia AB DHB Class II 2010-12-15
K101319 IMMULISA DSDNA ANTIBODY ELISA Immco Diagnostics, Inc. LRM Class II 2010-12-09
K102607 FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS Biomedical Diagnostics (Bmd) SA LLL Class II 2010-12-03
K093908 CCPOINT Euro-Diagnostica AB NHX Class II 2010-12-01
K101291 SCANVIEW HER2/NEU FISH SYSTEM Applied Spectral Imaging , Ltd. NTH Class II 2010-11-23
K100917 FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM Biomedical Diagnostics (Bmd) SA MOB Class II 2010-11-03
K100499 ORGENTEC RHEUMATOID FACTOR EIA Orgentec Diagnostika GmbH DHR Class II 2010-10-27
K094060 QUANTA FLASH H-TTG IGA Inova Diagnostics, Inc. MVM Class II 2010-10-13
K092599 IMMULISA MPO ANTIBODY ELISA Immco Diagnostics, Inc. MOB Class II 2010-10-07
K092601 IMMULISA ANCA SCREEN ELISA Immco Diagnostics, Inc. MOB Class II 2010-10-07
K092600 IMMULISA PR3 ANTIBODY ELISA Immco Diagnostics, Inc. MOB Class II 2010-10-07
K093107 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics DHB Class II 2010-09-30
K100017 EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM Euroimmun Us, Inc. OSK Class II 2010-09-13
K101203 TINA-QUANT ALBUMIN GEN 2 Roche Diagnostics DCF Class II 2010-09-10
K100853 COBAS 8000 MODULAR SERIES ANALYZER Roche Diagnostics Corp. DCF Class II 2010-09-09
K100455 SPAPLUS ANALYZER The Binding Site DBI Class II 2010-09-03
K092736 EUROIMMUN ANTI-M2-3E ELISA (IGG) Euroimmun Us, Inc. DBM Class II 2010-09-02
K091969 EUROIMMUN ANTI-DESMOGLEIN 1 ELISA (IGG), EUROIMMUN ANTI-DESMOGLEIN 3 ELISA (IGG) Euroimmun Us, Inc. NBO Class II 2010-09-02
K093954 BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Bio-Rad Laboratories NHX Class II 2010-08-24
K100588 HUMAN IGA2 KIT FOR USE ON THE SPAPLUS The Binding Site Group , Ltd. CFN Class II 2010-08-16
K100179 SPAPLUS The Binding Site Group , Ltd. CZW Class II 2010-08-13
K093459 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 Phadia US, Inc. MST Class II 2010-08-13
K092399 ANTI-MUTATED CITRULLINATED VIMENTIN EIA Orgentec Diagnostika GmbH OQZ Class II 2010-07-01
K100538 TINA-QUANT FERRITIN GEN. 4 Roche Diagnostics DBF Class II 2010-06-22
K091845 CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM Phadia US, Inc. MID Class II 2010-06-07
K091859 AESKU PR3 Aesku Diagnostics MOB Class II 2010-06-03
K091556 HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS Instrumentation Laboratory CO MSV Class II 2010-05-21
K092229 THYRETAIN TM TSI REPORTER BIOASSAY Diagnostic Hybrids, Inc. JZO Class II 2010-05-18
K091486 K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR Kamiya Biomedical Co. DCF Class II 2010-04-29
K091741 TINA-QUANT CERULOPLASMIN Roche Diagnostics CHN Class II 2010-03-18
K093957 ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, Fujirebio Diagnostics,Inc. OIU Class II 2010-03-18
K092181 HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS Instrumentation Laboratory CO MID Class II 2010-03-11
K091520 IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. MVM Class II 2010-03-10
K090753 THERATEST EL-ANTI-CCP/2 Theratest Laboratories, Inc. NHX Class II 2010-03-05
K082823 HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS The Binding Site Group , Ltd. CFN Class II 2010-03-01
K091860 AESKULISA MPO, MODEL 30-7303US Aesku Diagnostics MOB Class II 2010-02-23
K091522 IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA Immco Diagnostics, Inc. MST Class II 2010-02-04
K090755 QUANTA LITE APS/PT IGG AND IGM ELISA Inova Diagnostics, Inc. OPN Class II 2010-02-01
K092978 IMMUNOCAP RAPID READER, MODEL 12-3600-10 Phadia US, Inc. DHB Class II 2010-01-19
K091052 PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM Abaxis, Inc. DCN Class II 2010-01-15
K090920 HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) The Binding Site, Ltd. CFN Class II 2009-12-30
K092450 HUMAN IGD KIT FOR USE ON SPAPLUS The Binding Site CZJ Class II 2009-12-28
K083845 XTAG CF60 KIT V2 Luminex Molecular Diagnostics, Inc. NUA Class II 2009-12-11
K092505 BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 Beckman Coulter, Inc. DBF Class II 2009-12-11
K081092 MODIFICATION TO MAMMAPRINT Agendia NYI Class II 2009-12-11
K092050 IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 Phadia AB DHB Class II 2009-11-20
K091468 IVD TECHNOLOGIES ACHRAB TEST KIT Ivd Technologies NST Class II 2009-11-20
K091657 IMMUNOSCAN CCPLUS Euro-Diagnostica AB NHX Class II 2009-11-19
K083080 IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM Sqi Diagnostics Systems DHR Class II 2009-10-29
K091984 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 Siemens Medical Solutions Diagnostics DHB Class II 2009-10-28
K092283 DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG Siemens Healthcare Diagnostics DFZ Class II 2009-10-21
K083260 ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN Roche Diagnostics DDR Class II 2009-10-16
K092757 THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR Thera-Test Laboratories, Inc. MSV Class II 2009-10-09
K083868 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 Axis-Shield Diagnostics, Ltd. NHX Class II 2009-09-25
K083602 KAPPA LIGHT CHAINS SENTINEL CH. SpA DFH Class II 2009-09-03
K090760 THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 Theratest Laboratories, Inc. JZO Class II 2009-09-03
K083846 XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 Luminex Molecular Diagnostics, Inc. NUA Class II 2009-09-01
K083053 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) Euroimmun Us, Inc. MST Class II 2009-08-07
K091289 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics DHB Class II 2009-08-06
K083052 EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) Euroimmun Us, Inc. MST Class II 2009-07-28
K083294 VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TEST Nanosphere, Inc. NUA Class II 2009-07-24
K090901 ESENSOR CF GENOTYPING TESTM ESENSOR SYSTEM, ESENSOR CYSTIC FIBROSIS GENOTYPING TEST, ESENSOR INSTRUMENT, MODELS XT-8 Osmetech Molecular Diagnostics NUA Class II 2009-07-06
K083601 LAMBDA LIGHT CHAINS SENTINEL CH. SpA DEH Class II 2009-06-22
K080469 VIDAS CA 15-3 ASSAY bioMerieux, Inc. LTK Class II 2009-06-22
K083117 ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 Phadia US, Inc. LKO Class II 2009-05-28
K090257 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics DHB Class II 2009-05-26
K083391 THYROID STIMULATING IMMUNOGLOBULIN REPORTER ASSAY Diagnostic Hybrids, Inc. JZO Class II 2009-05-21
K083850 EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS Euroimmun Us, Inc. MOB Class II 2009-05-20
K083289 HUMAN BETA-2 MICROGLOBULIN KIT The Binding Site, Ltd. JZG Class II 2009-05-06
K090594 DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID Siemens Healthcare Diagnostics CFN Class II 2009-04-29

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