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Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
34
Latest Decision
1982-12-28

Clearances · page 32 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K823507 TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY Hybritech, Inc. DGC Class II 1982-12-28
K823403 ALLERCOAT POSITIVE CONTROL SERUM Kallestad Laboratories, Inc. DGC Class II 1982-12-15
K823470 ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. DHB Class II 1982-12-15
K822681 ANTI-NUCLEAR ANTIBODY TEST KIT (ANA) Amico Lab, Inc. DHN Class II 1982-12-13
K823416 PRISMA C-REACTIVE PROTEIN ASSAY Syva Co. DCK Class II 1982-12-09
K823415 PRISMA C-REACTIVE PROTEIN CONTROLS Syva Co. DCK Class II 1982-12-09
K823417 PRISMA-C-REACTIVE PROTEIN CALIBRATORS Syva Co. DCK Class II 1982-12-09
K822682 ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K Amico Lab, Inc. DHN Class II 1982-12-03
K823275 AUTOPAK FERRITIN TEST DELIVERY SYS Micromedic Systems DBF Class II 1982-12-03
K822678 FITC ANTISERA TO HUMAN GOBULIN Amico Lab, Inc. DFH Class II 1982-11-17
K822677 FITC ANTISERA TO HUMAN IGM Amico Lab, Inc. DFH Class II 1982-11-17
K823121 RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA Amico Lab, Inc. DFH Class II 1982-11-17
K822674 FITC ANTISERA TO HUMAN LAMBDA Amico Lab, Inc. DFH Class II 1982-11-17
K822675 FITC ANTISERA TO HUMAN IGA Amico Lab, Inc. DFH Class II 1982-11-17
K822667 ANTISERUM TO HUMAN LAMBDA Amico Lab, Inc. DFH Class II 1982-11-17
K822668 ANTISERUM TO HUMAN IGA Amico Lab, Inc. DFH Class II 1982-11-17
K822671 ANTISERUM TO HUMAN GOBULIN Amico Lab, Inc. DFH Class II 1982-11-17
K822679 FITC ANTISERA TO HUMAN C3 Amico Lab, Inc. DFH Class II 1982-11-17
K822666 ANTISERUM TO HUMAN KAPPA Amico Lab, Inc. DFH Class II 1982-11-17
K822676 FITC ANTISERA TO HUMAN IGG Amico Lab, Inc. DFH Class II 1982-11-17
K822669 ANTISERUM TO HUMAN IGG Amico Lab, Inc. DFH Class II 1982-11-17
K822673 FITC ANTISERA TO HUMAN KAPPA Amico Lab, Inc. DFH Class II 1982-11-17
K822670 ANTISERUM TO HUMAN IGM Amico Lab, Inc. DFH Class II 1982-11-17
K823107 QUANTIMETRIC 2 CERULOPLASMIN ASSAY Kallestad Laboratories, Inc. DDB Class II 1982-11-16
K822341 ALLERGENETICS IGE-FAST TEST Allergenetics DGC Class II 1982-11-10
K823009 GAMMA CLQ Gamma Medical Products, Inc. DAK Class II 1982-11-05
K823055 FLOUROSET IMMUNOFLUORESCENT ANTIBODY Immulok, Inc. DHN Class II 1982-11-05
K820945 SERA FOR ANTINUCLEAR ANTIBODIES Centers for Disease Control and Prevention DHN Class II 1982-10-26
K822613 RAST ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. DGC Class II 1982-10-22
K822911 ANAZYME ANA PEROXIDASE TEST SYSTEM Clinical Sciences, Inc. DAA Class II 1982-10-22
K822905 LATEST RF KIT FOR RHEUMATOID FACTOR Fisher Scientific Co., LLC DHR Class II 1982-10-18
K822346 HISTIMUNE ENZYME-ANA TEST Icl Scientific LJM Class II 1982-10-08
K822472 ANTISERA TO HUMAN FERRITIN Kent Laboratories, Inc. DBF Class II 1982-09-30
K822397 ANA HEP-2 FLUORO-KIT Clinical Sciences, Inc. DHN Class II 1982-09-21
K822607 ANTINUCLEAR ANTOBODY CELL SUBSTRATE Immulok, Inc. DHN Class II 1982-09-17
K822516 VIVONEX MASS GASTRASTOMY TUBE Norwich Eaton Pharmaceuticals, Inc. KHT Class I 1982-09-07
K822442 VAST VENTREX RAST ALLERGEN DISCS Ventrex Laboratories, Inc. DGC Class II 1982-09-02
K821949 ORTHO* ALTERNATIVE PATHWAY COMPL. TEST Ortho Diagnostic Systems, Inc. DAK Class II 1982-08-27
K821941 RHEUMATOID FACTOR REFERENCE PREPARA. Armkel, LLC DHR Class II 1982-08-27
K822206 TOTAL IGE DISCS Kallestad Laboratories, Inc. DGC Class II 1982-08-16
K822141 PHADEBAS RAST TEST Pharmacia, Inc. DHB Class II 1982-08-03
K822026 IMMUNO DIAGNOSTICS ASSAY Helena Laboratories CZP Class II 1982-08-03
K822067 EMIT C-REACTIVE PROTEIN AUTOCAROUSEL Syva Co. DCK Class II 1982-07-27
K821151 RIA-QUANT FPA TEST KIT Mallinckrodt Critical Care DAN Class II 1982-07-22
K821984 QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. Kallestad Laboratories, Inc. DCK Class II 1982-07-22
K821412 C-REACTIVE PROTEIN CONTROL Syva Co. DCK Class II 1982-07-22
K821898 ORTHO CLASSICAL PATHWAY COMPL. TEST Ortho Diagnostic Systems, Inc. DBA Class II 1982-07-16
K821388 SERO/TEX CRP TEST Texas Immunology, Inc. DCN Class II 1982-07-02
K821386 SERO/TEX MONO TEST Texas Immunology, Inc. KTN Class II 1982-07-02
K821806 ORTHO CLG IMMUNE COMPLEX TEST SYSTEM Ortho Diagnostic Systems, Inc. DAK Class II 1982-06-25
K821451 VAST VENTREX ALLERGY SYSTEMS TESTS Ventrex Laboratories, Inc. DHB Class II 1982-06-23
K821092 GAMMADAB[125]EGE RADIOIMMUNOASSAY IT Clinical Assays, Inc. DGC Class II 1982-06-22
K820977 VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD Ventrex Laboratories, Inc. DGC Class II 1982-06-11
K820978 VENTRE/SPEC ALLERGEN CONTROL-INHALANT Ventrex Laboratories, Inc. DGC Class II 1982-06-11
K821576 ANTINUCLEAR ANTIBODY SCREEN FLOURESC Immuno-Products Industries DBL Class II 1982-06-10
K821615 VAST VENTREX PD IGE RIA TEST SET Ventrex Laboratories, Inc. DGC Class II 1982-06-10
K821489 CORDIA TG Cordis Corp. JZO Class II 1982-06-09
K821385 SERO/TEX LE TEST Texas Immunology, Inc. DHC Class II 1982-05-28
K821413 EMIT C-REACTIVE PROTEIN ASSAY Syva Co. DCN Class II 1982-05-28
K821319 SERO/TEX RF TEST Texas Immunology, Inc. DHR Class II 1982-05-21
K821094 IP SPECIFIC E Diagnostic Reagent Tech. DGO Class II 1982-05-07
K820897 VENTRE/SPEC IGE CONTROLS Ventrex Laboratories, Inc. DGC Class II 1982-05-05
K821018 ANTIHUMAN IGG GLOBULIN FITC LABELED Microbiological Research Corp. DEW Class II 1982-04-29
K820900 EMIT URINE METHADONE ASSAY #3E319 Syva Co. DDE Class I 1982-04-26
K820896 VENTREX 125I ANTI-IGE ALLERGY ISOTOPE Ventrex Laboratories, Inc. DGC Class II 1982-04-21
K820298 CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV Ventrex Laboratories, Inc. DHX Class II 1982-04-08
K820029 KALLESTAD RAST REAGENTS Kallestad Laboratories, Inc. DHB Class II 1982-04-06
K820265 ANA TEST (MOUSE LIVER SUBSTRATE) Meloy Laboratories, Inc. DHN Class II 1982-02-12
K812485 DAKO PAP KIT K504 Dako Corp. DFH Class II 1982-02-10
K812484 DAKO PAP KIT K505 Dako Corp. DEW Class II 1982-02-10
K820088 AFT SYSTEM PROFICIENCY TESTING PROGRAM Calbiochem-Behring Corp. DBL Class II 1982-01-26
K813592 QUANTAFLUOR FLUORESCENT TEST REAGENTS Kallestad Laboratories, Inc. DHN Class II 1982-01-18
K813189 PHADEBAS/PHADEZYM IGE REAGENTS Pharmacia, Inc. DGC Class II 1981-12-31
K812985 AGGLUTEX MORPHINE TEST KIT Hoffmann-La Roche, Inc. DDF Class I 1981-12-31
K812901 125I FERRITIN RADIOIMMUNOASSAY KIT Bio-Ria DBF Class II 1981-12-30
K813508 SAC-CEL Burroughs Wellcome Co. KTS Class II 1981-12-29
K813309 RA-80 POSITIVE CONTROL Sun-Kit DHR Class II 1981-12-17
K813288 NEIA TRANSFERRIN ENZYMEIMMUNOASSAY New England Immunology Assoc. DDG Class II 1981-12-17
K812972 RA LATEX TEST Oxoid U.S.A., Inc. DHR Class II 1981-11-06
K812968 FIAX RHEUMATOID FACTOR TEST KIT Intl. Diagnostic Technology DHR Class II 1981-11-06
K812882 RHEUMATEX Armkel, LLC DHR Class II 1981-10-26
K812821 H-103 IGG, H-104 IGA, H-105 IGM Immulok, Inc. DFZ Class II 1981-10-26
K812881 IMMUNEX CRP Armkel, LLC DCN Class II 1981-10-26
K810592 NUCLEAR ANTIGENS Alpha Antigens, Inc. LLL Class II 1981-10-23
K812786 FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS Corning Medical & Scientific DBF Class II 1981-10-23
K812597 FERRITIN KIT Hybritech, Inc. DBF Class II 1981-10-19
K812664 ACA IMMUNOGLOBULIN G ANALYTICAL TEST E.I. Dupont DE Nemours & Co., Inc. DEW Class II 1981-10-02
K812633 ACA IMMUNOGLOBULIN A/M CALIBRATORS E.I. Dupont DE Nemours & Co., Inc. CZP Class II 1981-09-29
K812630 ACA IMMUNOGLOBULIN G CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DEW Class II 1981-09-29
K812661 IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA Dako Corp. DFH Class II 1981-09-29
K812631 ACA IMMUNOGLOBIN A TEST PACK E.I. Dupont DE Nemours & Co., Inc. CZP Class II 1981-09-29
K812632 ACA IMMUNOGLOBIN M TEST PACK E.I. Dupont DE Nemours & Co., Inc. DFT Class II 1981-09-29
K812658 CEA CONTROL PLASMA Pacific Hemostasis DHX Class II 1981-09-29
K812662 IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA Dako Corp. DEH Class II 1981-09-29
K812625 ACA PLASMINOGEN TEST PACK E.I. Dupont DE Nemours & Co., Inc. DDX Class I 1981-09-29
K812540 CORDIA IM Cordis Corp. KTN Class II 1981-09-24
K812453 SCRIPPSYSTEM IMMUNOGLOBIN RID KIT Scripps-Miles, Inc. DEW Class II 1981-09-23
K812522 RABBIT COMPLEMENT Dutchland Laboratories, Inc. KTQ Class I 1981-09-23
K812493 IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO Dako Corp. DEB Class II 1981-09-23
K812492 IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN Dako Corp. DDG Class II 1981-09-23

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