meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
40
Latest Decision
1992-09-14

Clearances · page 22 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K920087 IGE EIA TEST KIT The Binding Site, Ltd. DGO Class II 1992-09-14
K920401 IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST General Biometrics, Inc. MID Class II 1992-08-20
K923070 WAKO IGG-HA Wako Chemicals USA, Inc. CFN Class II 1992-08-20
K922417 AL-ACID GLYCOPROTEIN RID KIT The Binding Site, Ltd. LKL Class I 1992-08-20
K914959 MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. DHB Class II 1992-08-20
K920400 IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST General Biometrics, Inc. MID Class II 1992-08-20
K922047 IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 Medix Biotech, Inc. DGC Class II 1992-08-05
K921265 DIASTAT ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd. MID Class II 1992-08-03
K921574 WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC Hycor Biomedical, Inc. DHB Class II 1992-08-03
K915829 IL TEST(TM) HAPTOGLOBIN (HPT) Instrumentation Laboratory CO DAD Class II 1992-07-29
K920005 IL TEST ALPHA-1-ANTITRYPSIN (AAT) Instrumentation Laboratory CO DEM Class II 1992-07-29
K921787 SYNELISA TPO ANTIBODIES Elias U.S.A., Inc. JNL Class II 1992-07-28
K922151 WAKO AUTOKIT RF Wako Chemicals USA, Inc. DHR Class II 1992-07-28
K922538 VENTREX ALLERGEN DISC Hycor Biomedical, Inc. DHB Class II 1992-07-27
K922125 STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. DDR Class II 1992-07-21
K922387 DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL Baxter Diagnostics, Inc. DDR Class II 1992-07-15
K920616 DIASTAT ANTI-HISTONE KIT Shield Diagnostics, Ltd. LJM Class II 1992-07-14
K922297 INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST Ampcor, Inc. KTN Class II 1992-07-14
K922296 IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST Ampcor, Inc. KTN Class II 1992-07-14
K920829 COBAS CORE FERRITIN EIA Roche Diagnostic Systems, Inc. JMG Class II 1992-06-19
K921183 DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT Shield Diagnostics, Ltd. DBM Class II 1992-06-19
K920014 IL TEST IMMUNOGLOBULIN A Instrumentation Laboratory CO CZP Class II 1992-06-16
K920007 IL TEST COMPLEMENT 3 Instrumentation Laboratory CO CZW Class II 1992-06-16
K920318 CEDIA FERRITIN ASSAY Microgenics Corp. JMG Class II 1992-06-04
K921250 SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. MID Class II 1992-06-04
K920132 SYN ELISA BETA 2 MICROGLOBULIN TEST KIT Elias U.S.A., Inc. JZG Class II 1992-05-28
K921575 IGG SUCLASS EIA Virotech Diagnostika DEW Class II 1992-05-28
K914454 THE THERATEST EL-ANA PROFILES Theratest Laboratories, Inc. LKJ Class II 1992-05-22
K920600 DAB DETECTION KIT Ventana Medical Systems, Inc. DEY Class II 1992-05-11
K920566 AEC DETECTION KIT Ventana Medical Systems, Inc. DEY Class II 1992-05-08
K913342 AUTOSTAT(TM) ANTI-DSNA Cogent Diagnotics , Ltd. LKJ Class II 1992-05-01
K920372 ACS TOTAL IGE IMMUNOASSAY Ciba Corning Diagnostics Corp. DGC Class II 1992-04-08
K915135 SYNELISA TGAB/TMAB Elias U.S.A., Inc. JZO Class II 1992-04-08
K915133 SYNELISA TMAB Elias U.S.A., Inc. JZO Class II 1992-04-08
K915134 SYNELISA TGAB Elias U.S.A., Inc. JZO Class II 1992-04-08
K920952 VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY Vitek Systems, Inc. DBF Class II 1992-04-07
K915420 HEMAGEN ENA [JO-1] KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1992-04-07
K920753 RF STAT IGM TEST KIT Biowhittaker Molecular Applications, Inc. DHR Class II 1992-03-30
K920385 ANTI-ENA ANTIBODY TEST (SM) Immco Diagnostics, Inc. LLL Class II 1992-03-30
K920386 ANTI-ENA ANTIBODY TEST KIT Immco Diagnostics, Inc. LLL Class II 1992-03-30
K915429 KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT Kronus JZO Class II 1992-03-30
K920384 ANIT-ENA ANTIBODY TEST [SS-B (LA)] Immco Diagnostics, Inc. LLL Class II 1992-03-30
K915233 MYOGLOBIN RIA TEST KIT Pro Diagnostics, Inc. DDR Class II 1992-03-30
K915428 KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT Kronus JZO Class II 1992-03-30
K920383 ANTI-ENA ANTIBODY TEST [SS-A (RO)] Immco Diagnostics, Inc. LLL Class II 1992-03-30
K915650 HUMAN IGG SUBCLASS RID KIT Janssen Biochimica CGM Class II 1992-03-26
K915838 OPUS FERRITIN TEST SYSTEM Pb Diagnostic Systems, Inc. DGE Class II 1992-03-18
K920150 ENCORE SCL-70 Clark Laboratories, Inc. LKJ Class II 1992-03-18
K915508 DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500) Diagnostic Systems Laboratories, Inc. JZG Class II 1992-03-17
K920300 B2-MICROGLOBULIN RADIOIMMUNOASSAY Nichols Institute JZG Class II 1992-03-17
K915850 OPUS MYOGLOBIN TEST SYSTEM Pb Diagnostic Systems, Inc. DDR Class II 1992-03-17
K915272 HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) Hemagen Diagnostics, Inc. LJM Class II 1992-03-17
K914554 SPECIFIC IGE EIA-TURBO ASSAY Ventrex Laboratories, Inc. DHB Class II 1992-03-13
K920221 HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY Akers Research Corp. KTN Class II 1992-03-13
K920006 IL TEST IMMUNOGLOBULIN G (IGG) Instrumentation Laboratory CO CGM Class II 1992-03-13
K920220 HEALTHTEST RHEUMATOID FACTOR ASSAY Akers Research Corp. DHR Class II 1992-03-13
K920010 IL TEST COMPLEMENT 4 Instrumentation Laboratory CO DBI Class II 1992-03-13
K920008 IL TEST IMMUNOGLOBULIN M (IGM) Instrumentation Laboratory CO CGM Class II 1992-03-11
K920370 ISOTYPES HUMAN IGG SUBCLASS EIA KIT Isotypes, Inc. CGM Class II 1992-03-11
K920124 TURBIQUANT Behring Diagnostics, Inc. DHR Class II 1992-03-02
K913833 VENTREX ALLERGEN DISC Ventrex Laboratories, Inc. DHB Class II 1992-02-21
K915282 HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1992-02-12
K914550 ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM Diagnostic Resources, Inc. LKJ Class II 1992-02-11
K920046 MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT Medix Biotech, Inc. DBF Class II 1992-01-28
K914993 IL TEST(TM) TRANSFERRIN (TRF) Instrumentation Laboratory CO DDG Class II 1992-01-17
K915431 COMPLEMENT C1 INACTIVATOR KIT The Binding Site, Ltd. DBA Class II 1992-01-17
K914853 ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT Reads Medical Products, Inc. LJM Class II 1992-01-15
K914155 TIA CRP TEST KIT Crestat Diagnostics, Inc. DCK Class II 1992-01-15
K914389 ALPHA-2 MACROGLOBULIN TEST RID KIT The Binding Site, Ltd. DEB Class II 1991-12-20
K915234 HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1991-12-20
K913672 PREALBUMIN IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. JZJ Class I 1991-12-20
K913668 CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. DDB Class II 1991-12-20
K915058 HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1991-12-20
K914405 READS(R) IGA ANTI-CARDIOLIPIN TEST KIT Reads Medical Products, Inc. MID Class II 1991-12-18
K914391 ALBUMIN TEST RID KIT The Binding Site, Ltd. DCF Class II 1991-12-10
K914801 IMMUNOWELL DSDNA ANTIBODY TEST General Biometrics, Inc. DHC Class II 1991-12-09
K914390 TRANSFERRIN RID KIT The Binding Site, Ltd. DDG Class II 1991-12-09
K914850 CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE Mast Immunosystems DHB Class II 1991-12-09
K911661 ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM Immuno Concepts, Inc. MID Class II 1991-12-09
K913666 ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. DEM Class II 1991-12-09
K913670 HAPTOGLOBIN IMMUNOLOGICAL TEST KIT The Binding Site, Ltd. DAB Class II 1991-12-09
K913671 HUMAN IGD IMMUNOLOGICAL NL TEST KIT The Binding Site, Ltd. CZJ Class II 1991-12-02
K913150 ABBOTT MATRIX AERO PLUS SYSTEM Abbott Laboratories DHB Class II 1991-11-29
K913054 3M ANTI-CARDIOLIPIN FAST(TM) TEST 3M Diagnostic Systems, Inc. MID Class II 1991-11-27
K914225 ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JZG Class II 1991-11-22
K912294 ALLERGY INFORMATION MANAGER Diagnostic Products Corp. DHB Class II 1991-11-22
K913212 3M IGE SINGLE POINT FAST TEST Whittaker Bioproducts, Inc. DHB Class II 1991-11-22
K911680 QUANTA LITE(TM) ACA Inova Diagnostics, Inc. MID Class II 1991-11-19
K913653 3M ANTI-DSDNA FAST TEST 3M Diagnostic Systems, Inc. LRM Class II 1991-11-07
K913131 HUMAN BETA-2 MICROGLOBIN EN-RID KIT The Binding Site, Ltd. JZG Class II 1991-11-07
K913041 ANTI-DSDNA ANTIBODY TEST Helix Diagnostics, Inc. LLL Class II 1991-11-05
K914388 C1 RID KIT The Binding Site, Ltd. DAK Class II 1991-10-28
K913892 FASTTECH SYSTEM II 3M Diagnostic Systems, Inc. DHB Class II 1991-10-02
K911679 ANTI-JO-1 MICROASSAY Diamedix Corp. LLL Class II 1991-09-23
K912020 ANTI-DNA MICROASSAY Diamedix Corp. LRM Class II 1991-09-23
K911881 DSL BETA 2 MICROGLOBULIN (DSL 6200) Diagnostic Systems Laboratories, Inc. JZG Class II 1991-09-10
K904181 ANTI-GBM ANTIBODIES QUANTITATIVE KIT Biochemical Diagnostic, Inc. DBL Class II 1991-09-10
K912173 DSL BETA 2 MICROGLOBULIN (DSL 6100) Diagnostic Systems Laboratories, Inc. JZG Class II 1991-08-13
K911903 ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA Pharmacia, Inc. DHB Class II 1991-08-12
K912582 MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. DHB Class II 1991-07-31

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