meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
42
Latest Decision
1999-01-29

Clearances · page 14 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K983289 APOLIPOPROTEIN A1 Abbott Laboratories DER Class II 1999-01-29
K984132 IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 Diagnostic Products Corp. DCK Class II 1999-01-28
K982634 DRYSPOT INFECTIOUS MONONUCLEOSIS KIT Oxoid , Ltd. KTN Class II 1999-01-28
K984137 QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA Inova Diagnostics, Inc. MVM Class II 1999-01-28
K983655 AUTOSTAT II ANA SCREEN ELISA Cogent Diagnotics , Ltd. LJM Class II 1999-01-28
K983281 APOB Abbott Laboratories DFC Class II 1999-01-26
K983992 NICHOLS ADVANTAGE THYROGLOBULIN AUTOANTIBODIES (TGAB) ASSAY Nichols Institute Diagnostics JZO Class II 1999-01-26
K984045 RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS Kamiya Biomedical Co. DHR Class II 1999-01-25
K984516 THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET Zeus Scientific, Inc. MOB Class II 1999-01-11
K983921 AUTOSTAT II ENA SCREEN ELISA Cogent Diagnotics , Ltd. LLL Class II 1998-12-28
K984145 OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT Olympus Diagnostica GmbH DDR Class II 1998-12-23
K984173 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM Zeus Scientific, Inc. MID Class II 1998-12-22
K984475 LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 Bio-Rad LKJ Class II 1998-12-22
K984462 LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 Bio-Rad LLL Class II 1998-12-22
K982434 REAADS IGA ANTI-B2GP 1 TEST KIT Corgenix, Inc. MSV Class II 1998-12-22
K984476 LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 Bio-Rad LKO Class II 1998-12-22
K984473 LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 Bio-Rad LKJ Class II 1998-12-22
K984470 LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 Bio-Rad LKJ Class II 1998-12-22
K984464 LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 Bio-Rad LKJ Class II 1998-12-22
K984479 LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 Bio-Rad LKP Class II 1998-12-22
K984478 LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 Bio-Rad LKJ Class II 1998-12-22
K983031 VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY Ortho-Clinical Diagnostics, Inc. LOJ Class II 1998-12-18
K984397 LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 Bio-Rad DHN Class II 1998-12-18
K984399 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 Bio-Rad DHN Class II 1998-12-18
K984398 LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 Bio-Rad DHN Class II 1998-12-18
K984400 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 Bio-Rad DHN Class II 1998-12-18
K983880 TRANSFERRIN SPQ III ANTIBODY REAGENT SET DiaSorin, Inc. DDG Class II 1998-12-18
K984396 LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 Bio-Rad LRM Class II 1998-12-18
K983924 HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO Immuno Concepts, Inc. DHN Class II 1998-12-18
K983954 ALASTAT MICROPLATE MIXED ALLERGEN PANELS Diagnostic Products Corp. DHB Class II 1998-12-17
K984347 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F Zeus Scientific, Inc. MID Class II 1998-12-17
K984175 THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM Zeus Scientific, Inc. MID Class II 1998-12-17
K984315 THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE Zeus Scientific, Inc. MOB Class II 1998-12-17
K983340 IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR Beckman Coulter, Inc. DBF Class II 1998-12-14
K984065 STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK Dade Behring, Inc. DDR Class II 1998-12-14
K984191 MYOGLOBIN FLEX REAGENT CARTRIDGE Dade Behring, Inc. DDR Class II 1998-12-10
K981946 CLEARVIEW IM Unipath , Ltd. KTN Class II 1998-12-10
K974845 BTA STAT TEST PRESCRIPTION HOME USE Bard Diagnostic Sciences,Inc. MMW Class II 1998-12-08
K982433 REAADS IGM ANTI-B2GP1 TEST KIT Corgenix, Inc. MSV Class II 1998-12-07
K983263 IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 Diagnostic Products Corp. LOJ Class II 1998-12-07
K983759 ABBOTT ARCHITECT FERRITIN Abbott Laboratories DBF Class II 1998-12-07
K982391 REAADS IGG ANTI-B2GPI TEST KIT Corgenix, Inc. MSV Class II 1998-12-07
K983553 ANTI-TG IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. JZO Class II 1998-12-07
K981912 HUMAN IGA SUBCLASS BNII COMBI KIT The Binding Site, Ltd. CFN Class II 1998-12-04
K984034 THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR Zeus Scientific, Inc. MOB Class II 1998-11-30
K982898 IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM Immco Diagnostics, Inc. MOB Class II 1998-11-30
K983895 IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT Beckman Coulter, Inc. JZG Class II 1998-11-25
K983970 IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 Diagnostic Products Corp. DDR Class II 1998-11-25
K983422 THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET Zeus Scientific, Inc. LRM Class II 1998-11-18
K983378 THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. Zeus Scientific, Inc. LJM Class II 1998-11-18
K983423 THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. LLL Class II 1998-11-18
K983465 THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. LKO Class II 1998-11-18
K983390 IS-ANTI-MPO IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. MOB Class II 1998-11-18
K983426 THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC Zeus Scientific, Inc. LLL Class II 1998-11-18
K983418 THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL Zeus Scientific, Inc. DHR Class II 1998-11-18
K983425 THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET Zeus Scientific, Inc. LLL Class II 1998-11-18
K983464 THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE Zeus Scientific, Inc. LLL Class II 1998-11-18
K983420 THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO Zeus Scientific, Inc. LKP Class II 1998-11-18
K983740 IS-ANTI-PR3 IGG ELISA TEST SYSTEM Columbia Bioscience, Inc. MOB Class II 1998-11-18
K983376 THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S Zeus Scientific, Inc. LLL Class II 1998-11-18
K983848 ABBOTT AXSYM MYOGLOBIN Abbott Laboratories DDR Class II 1998-11-16
K983185 BOEHRINGER MANNHEIM TINA-QUANT IGE TEST Boehringer Mannheim Corp. DGC Class II 1998-11-12
K981871 C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 Diagnostic Systems Laboratories, Inc. DCK Class II 1998-11-09
K983221 IGG Abbott Laboratories DEW Class II 1998-11-04
K983132 IGM Abbott Laboratories DFT Class II 1998-11-04
K983084 QUANTA LITE RF IGA ELISA Inova Diagnostics, Inc. DHR Class II 1998-11-04
K983356 C4 Abbott Laboratories DBI Class II 1998-11-04
K983441 C3 Abbott Laboratories CZW Class II 1998-11-04
K982639 SPIFE URINE IFE Helena Laboratories DAO Class II 1998-11-04
K983083 QUANTA LITE RF IGG ELISA Inova Diagnostics, Inc. DHR Class II 1998-11-04
K983359 IGA Abbott Laboratories CZP Class II 1998-11-04
K983167 TRF Abbott Laboratories DDG Class II 1998-11-04
K982948 ELECSYS PSA, MODEL # ELECSYS 1010 Boehringer Mannheim Corp. LTJ Class II 1998-10-27
K982949 ELECSYS PSA, MODEL 2010 Boehringer Mannheim Corp. LTJ Class II 1998-10-27
K981209 MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS The Binding Site, Ltd. MVM Class II 1998-10-22
K982701 UNICAP GLIADIN IGG ASSAY Pharmacia & Upjohn Co. MST Class II 1998-10-22
K982533 UNICAP GLIADIN IGA ASSAY Pharmacia & Upjohn Co. MST Class II 1998-10-22
K982714 BAYER IMMUNO 1 SYSTEM FERRITIN ASSAY Bayer Corp. DBF Class II 1998-10-22
K981208 TFR Ramco Laboratories, Inc. JNM Class II 1998-10-21
K982866 NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID PEROXIDASE AUTOANTIBODIES IMMUNOASSAY, MODEL # 62-701521 Nichols Institute Diagnostics JZO Class II 1998-10-16
K980724 TINAQUANT B 2-MICROGLOBULIN ASSAY Boehringer Mannheim Corp. JZG Class II 1998-10-16
K982879 SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY Shield Diagnostics, Ltd. MSV Class II 1998-10-15
K983391 IMMULITE 2000 OM-MA MODEL L2KOP2 Diagnostic Products Corp. LTK Class II 1998-10-15
K982680 CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY Chiron Diagnostics Corp. MOI Class II 1998-10-15
K981634 BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRIDGES, BIOCIRCUITS IOS PSA CONTROLS Biocircuits Corp. LTJ Class II 1998-10-13
K981521 AIA-PACK TPOAB ASSAY Tosoh Medics, Inc. JZO Class II 1998-10-08
K981522 AIA-PACK TGAB ASSAY Tosoh Medics, Inc. JZO Class II 1998-10-08
K982679 MULTIQUANT (R) QUANTITATIVE MYOGLOBIN TEST Spectral Diagnostics, Inc. DDR Class II 1998-10-07
K981048 HYDRAGEL 6 CSF KIT Morax CFF Class II 1998-10-07
K982603 QUANTA LITE CHROMATIN ELISA Inova Diagnostics, Inc. LLL Class II 1998-10-07
K980812 IMX HOMOCYSTEINE Axis Biochemicals, Asa DFC Class II 1998-10-01
K973203 THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES Sangstat Medical Corp. DAK Class II 1998-09-30
K982382 COBAS INTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. CFN Class II 1998-09-28
K983176 ELECSYS MYOGLOBIN STAT ASSAY Boehringer Mannheim Corp. DDR Class II 1998-09-24
K981985 ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 Beckman Coulter, Inc. DHX Class II 1998-09-24
K981297 IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 Diagnostic Products Corp. LTK Class II 1998-09-18
K982121 ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT Trace Scientific , Ltd. DBM Class II 1998-09-17
K982343 ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3 Pharmacia & Upjohn Co. DHB Class II 1998-09-15
K982023 PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT Inova Diagnostics, Inc. DAS Class I 1998-09-04
K981644 BINDAZYME ANTIGLIADIN IGG The Binding Site, Ltd. MST Class II 1998-09-03

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