meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
32
Latest Decision
1993-07-06

Clearances · page 21 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932225 ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM Immuno Concepts, Inc. MID Class II 1993-07-06
K930209 SYNELISA RO ABS / LA ABS Elias U.S.A., Inc. LJM Class II 1993-06-11
K930984 ACCESS(R) TOTAL IGE ASSAY Bio-Rad Laboratories, Inc. DGC Class II 1993-06-09
K912551 ANTI-ENDOMYSIAL ANTIBODY TEST Immco Diagnostics, Inc. DBL Class II 1993-06-09
K931224 VIDAS TOTAL IGE (IGE) ASSAY Biomerieux Vitek, Inc. DGP Class II 1993-05-20
K926114 HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM Tissue Culture Biotec, Inc. DHN Class II 1993-05-20
K924946 ELISA-DOXA SSB Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924951 ELISA-DOXA COMBI-4 Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924948 ELISA-DOXA SM/RNP Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924950 ELISA-DOXA JO-1 Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924945 ELISA-DPXA SSA KIT Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924947 ELISA-DOXA SM Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924949 ELISA-DOXA SCL-70 Advanced Biological Products, Inc. LLL Class II 1993-05-19
K924952 ELISA-DOXA COMBI-6 Advanced Biological Products, Inc. LLL Class II 1993-05-19
K931311 THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT Nichols Institute JZO Class II 1993-05-14
K925044 VENTREX ALLERGEN DISC Ventrex, Inc. DHB Class II 1993-05-14
K930143 AYNELISA M2-ANTIBODIES Elias U.S.A., Inc. DBM Class II 1993-05-11
K930141 SYNELISA SM ABS/RNP-SM ABS Elias U.S.A., Inc. LKP Class II 1993-05-11
K930142 SYNELISA U1-SNRNP (68KDA)-ANTIBODIES Elias U.S.A., Inc. LKO Class II 1993-05-11
K931247 TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 Helena Laboratories DAH Class II 1993-04-27
K930777 THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT Nichols Institute JNL Class II 1993-04-08
K926569 IMMUNO RA UNDILUTED Immunostics Co., Inc. DHR Class II 1993-04-06
K930281 SYNELISA JO-1 ANTIBODIES Elias U.S.A., Inc. LLL Class II 1993-04-06
K930417 SYNELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. LLL Class II 1993-04-06
K930757 RHEUMELISA II JO-1 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. LLL Class II 1993-03-26
K930130 RHEUMELISA II SCL-70 ANTIBODY TEST KIT Biowhittaker Molecular Applications, Inc. LLL Class II 1993-03-23
K921658 ANTI-DSDNA ANTIBODY TEST Immco Diagnostics, Inc. LSW Class II 1993-03-22
K924857 AIA-PACK CEA CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. DHX Class II 1993-03-18
K930485 QUANTA LITE(TM) THYROID M ELISA Inova Diagnostics, Inc. JZO Class II 1993-03-16
K930486 QUANTA LITE(TM) THYROID T ELISA Inova Diagnostics, Inc. DDC Class II 1993-03-15
K930621 TINA-QUANT CRP Boehringer Mannheim Corp. DCK Class II 1993-03-10
K930421 ELIAS DSDNA ABS Elias U.S.A., Inc. DHC Class II 1993-03-10
K930247 HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. DHC Class II 1993-03-10
K926562 QUANTA LITE(TM) JO-1 ELISA KIT Inova Diagnostics, Inc. LLL Class II 1993-03-04
K925183 BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST Princeton Biomedix KTN Class II 1993-02-23
K924767 IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC The Binding Site, Ltd. CFF Class II 1993-02-23
K930274 THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME Joldon Diagnostics JZO Class II 1993-02-23
K923420 CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY Ciba Corning Diagnostics Corp. DHB Class II 1993-02-23
K924769 IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC The Binding Site, Ltd. CFF Class II 1993-02-23
K923079 IL TEST CALIBRATION SET APO A1B Instrumentation Laboratory CO DFC Class II 1993-02-05
K924578 PSA ANTIBODY KIT Ventana Medical Systems, Inc. DFD Class II 1993-02-05
K925194 THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT Joldon Diagnostics JZO Class II 1993-02-05
K924629 PAP ANTIBODY KIT Ventana Medical Systems, Inc. DFD Class II 1993-02-04
K925118 EN TYPING CIE KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. LLL Class II 1993-02-02
K925826 ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA Clark Laboratories, Inc. JZO Class II 1993-01-26
K925785 AUTOSTAT ANTI-THYROID MICROSOMAL KIT Cogent Diagnotics , Ltd. JZO Class II 1993-01-21
K925784 AUTOSTAT ANTITHYROGLOBIN Cogent Diagnotics , Ltd. JZO Class II 1993-01-21
K925923 ELIAS TMAB Elias U.S.A., Inc. JZO Class II 1993-01-14
K925425 SPECIFIC IGE EIA-TURBO ASSAY Hycor Biomedical, Inc. DHB Class II 1993-01-14
K925922 ELIAS TGAB Elias U.S.A., Inc. JZO Class II 1993-01-14
K925848 IMMULITE FERRITIN Diagnostic Products Corp. JMG Class II 1993-01-13
K926221 ACCESS FERRITIN ASSAY Bio-Rad Laboratories, Inc. JMG Class II 1993-01-13
K924262 ENA SCREENING CIE KIT FOR DIAGNOSTIC USE The Binding Site, Ltd. LLL Class II 1992-12-29
K924186 LPIA-FERRITIN ASSAY Seradyn, Inc. DEF Class I 1992-12-23
K923537 ENCORE DS-DNA Clark Laboratories, Inc. LRM Class II 1992-12-23
K924197 ZORBA(TM) IGG REMOVAL REAGENT Zeus Scientific, Inc. DEW Class II 1992-12-15
K924898 QUANTA LITE(TM) SCL-70 ELISA Inova Diagnostics, Inc. LLL Class II 1992-12-15
K924858 AIA-PACK FER CALIBRATION VERIFICATION TEST SET Tosoh Medics, Inc. DBF Class II 1992-12-15
K915320 RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST Trinity Laboratories, Inc. DHR Class II 1992-12-07
K924332 ACCUTEX CRP LATEX TEST J.S. Medical Assoc. DCK Class II 1992-12-07
K920845 VIGIL II Beckman Instruments, Inc. DCK Class II 1992-12-07
K924044 VENTREX ALLERGEN DISC Hycor Biomedical, Inc. DHB Class II 1992-12-01
K924843 IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL General Biometrics, Inc. LLL Class II 1992-12-01
K921572 ENCORE SM Clark Laboratories, Inc. LLL Class II 1992-12-01
K924036 ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST J.S. Medical Assoc. DHR Class II 1992-12-01
K921870 ENCORE SM/RNP Clark Laboratories, Inc. LLL Class II 1992-12-01
K921132 SYN ELISA DSDNA ANTIBODIES Elias U.S.A., Inc. LKJ Class II 1992-12-01
K923768 PULSE CRP TEST Pulse Scientific, Inc. DCK Class II 1992-12-01
K924421 SYNELISA CARDIOLIPIN ANTIBODIES Elias U.S.A., Inc. MID Class II 1992-11-30
K924119 VENTREX ALLERGEN DISC Ventrex, Inc. DHB Class II 1992-11-30
K922241 AUTOZYME Cambridge Life Sciences Plc. LLL Class II 1992-11-30
K924209 VENTREX ALLERGEN DISC Hycor Biomedical, Inc. DHB Class II 1992-11-30
K923832 PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION Kabi Pharmacia, Inc. DGC Class II 1992-11-25
K923195 MYOGLOBIN ELISA TEST KIT Immuno Diagnostic Center, Inc. DDR Class II 1992-11-06
K923658 REP IMMUNOFIX Helena Laboratories CFF Class II 1992-11-02
K924087 KALESTAD ANA MICROPLATE EIA Bio-Rad Laboratories, Inc. LJM Class II 1992-11-02
K924248 ACCUTEX SLE LATEX TEST J.S. Medical Assoc. LJM Class II 1992-11-02
K924037 ACCUTEX IM RBC TEST J.S. Medical Assoc. KTN Class II 1992-11-02
K922340 ENCORE SS-B Clark Laboratories, Inc. LLL Class II 1992-10-16
K923767 PULSE IM RED CELL TEST Pulse Scientific, Inc. KTN Class II 1992-10-16
K922157 ENCORE SS-A Clark Laboratories, Inc. LLL Class II 1992-10-13
K923578 LIQUICHEK RHEUMATOID FACTOR CONTROL Bio-Rad DHR Class II 1992-10-06
K923771 PULSE RF TEST Pulse Scientific, Inc. DHR Class II 1992-10-05
K922722 TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL Simplicity Diagnostics, Inc. DCK Class II 1992-10-05
K922725 TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL Simplicity Diagnostics, Inc. DHR Class II 1992-10-05
K922726 TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL Simplicity Diagnostics, Inc. KTN Class II 1992-10-05
K922351 QUANTA LITE(TM) IGA ACA Inova Diagnostics, Inc. MID Class II 1992-09-29
K923320 QUANTA LITE ACA SCREEN Inova Diagnostics, Inc. MID Class II 1992-09-28
K923284 BASELINE CALIBRATION VERIFICATION CONTROLS Hycor Biomedical, Inc. DHB Class II 1992-09-28
K924056 ENCORE RHEUMATOID FACTOR EIA Clark Laboratories, Inc. DHR Class II 1992-09-25
K923886 DIASTAT TOTAL ANTI-CARDIOLIPIN KIT Shield Diagnostics, Ltd. MID Class II 1992-09-25
K923421 COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY Coulter Corp. JZG Class II 1992-09-23
K923371 AUTOSTAT ANTI-THYROID MICROSSOMAL Cogent Diagnotics , Ltd. JNL Class II 1992-09-22
K923370 AUTOSTAT ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd. JNL Class II 1992-09-22
K922829 QUANTA LITE ENA ELISA Inova Diagnostics, Inc. LLL Class II 1992-09-18
K922832 QUANTA LITE SS-B ELISA Inova Diagnostics, Inc. LLL Class II 1992-09-18
K922831 QUANTA LITE SM ELISA Inova Diagnostics, Inc. LLL Class II 1992-09-18
K922830 QUANTA LITE SS-A ELISA Inova Diagnostics, Inc. LLL Class II 1992-09-18
K922833 QUANTA LITE RNP ELISA Inova Diagnostics, Inc. LLL Class II 1992-09-18
K914685 866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS In Vitro Technologies, Inc. DHB Class II 1992-09-14

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