meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
43
Latest Decision
1984-10-22

Clearances · page 30 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K843710 ELISA FOR TOTAL IGE Scientific Research DGC Class II 1984-10-22
K841580 TSH RECEPTOR ANTIBODY KIT 125I TSH Clinetics Corp. JZO Class II 1984-10-22
K843570 FIAX HAPTOGLOBIN TEST KIT Intl. Diagnostic Technology DAB Class II 1984-10-05
K843347 RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON E.I. Dupont DE Nemours & Co., Inc. DHN Class II 1984-10-05
K843614 CORNING IMMUNOFIXATION SYS Corning Medical & Scientific CZP Class II 1984-10-05
K843302 NEW ALLERG. COATED MICROFILTER WELL STRI Diagnostic Reagent Tech. DHB Class II 1984-10-04
K843408 ENCORE IGE REAGENT Hybritech, Inc. DGC Class II 1984-10-01
K842533 AMIZYME-ANDNA TEST KIT Amico Lab, Inc. LJM Class II 1984-09-20
K842532 AMIZYME-ANA TEST KIT Amico Lab, Inc. LJM Class II 1984-09-20
K843356 FIAX 100 FLUOROMETER Intl. Diagnostic Technology JZT Class I 1984-09-17
K843181 AUTOFLUOR IV SYSTEM Tech America Diagnostics DBM Class II 1984-09-17
K842468 TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG Miles Laboratories, Inc. CZP Class II 1984-08-28
K842470 TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM Miles Laboratories, Inc. DFH Class II 1984-08-28
K842749 FIAX TOTAL IGE TEST KIT Intl. Diagnostic Technology DGP Class II 1984-08-28
K842969 ALLERGENETICS ALLER-SPECIFIC IGE SERUM Allergenetics DGP Class II 1984-08-28
K842707 ADP NDNA IFA TEST Apple Diagnostic Products KTL Class II 1984-08-21
K842328 AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN Bartels Immunodiagnostic Supplies, Inc. DEH Class II 1984-08-03
K842327 AMER. HISTO-ID SYS PRIMARY IGM S7920-31 Bartels Immunodiagnostic Supplies, Inc. DFT Class II 1984-08-02
K842329 AMER. HISTO-ID SYS PRIMARY IGG S7920-11 Bartels Immunodiagnostic Supplies, Inc. DEW Class II 1984-08-02
K842330 AMER. HISTO-ID SYS PRIMARY IGA 2720-21 Bartels Immunodiagnostic Supplies, Inc. CZP Class II 1984-08-02
K842326 AMER. HISTO-ID SYS PRIMARY KIT Bartels Immunodiagnostic Supplies, Inc. DFH Class II 1984-08-02
K842071 FIAX TRANSFERRIN TEST KIT Intl. Diagnostic Technology DDI Class II 1984-07-11
K841864 QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT Kallestad Laboratories, Inc. DEH Class II 1984-07-11
K842484 LEAP LE TEST KIT Cooper Biomedical, Inc. LKJ Class II 1984-07-11
K842457 PHADEXACT SERUM, ALLERGEN SPECIFIC IGE Pharmacia, Inc. DHB Class II 1984-07-02
K842247 MELOY AUTOANTIBODY TEST SYS Meloy Laboratories, Inc. DBM Class II 1984-06-26
K841930 ENZYMATIC ACETAMINOPHEN ASSAY Diagnostic Chemicals, Ltd. (Usa) LKP Class II 1984-06-25
K841776 ANA SENSITIVITY/SPECIFICITY CONTROL Behring Diagnostics, Inc. DHN Class II 1984-06-22
K841816 OPTIMATE IGG TEST Miles Laboratories, Inc. DEW Class II 1984-06-22
K841814 OPTIMATE IGM TEST Miles Laboratories, Inc. DFT Class II 1984-06-22
K833275 GMP CIQ ELISA TEST KIT Gamma Medical Products, Inc. DAK Class II 1984-06-22
K842183 ADP ANA IFA TEST Apple Diagnostic Products DHN Class II 1984-06-22
K841114 ALLO-TYPE HUMAN IMMUNOGLOBULIN- Genetic Testing Institute DGX Class I 1984-06-14
K841862 IMMU-TEC Medilab Corp. DCK Class II 1984-06-13
K841863 MONO-TEC Medilab Corp. KTN Class II 1984-06-13
K833636 ORTHO* SERUM ELISA TEST SYSTEM Ortho Diagnostic Systems, Inc. DAK Class II 1984-06-13
K841992 MODIFICATION TO ACS CORONARY GUIDING Advanced Cardiovascular Systems, Inc. DAO Class II 1984-06-11
K841824 PHARMACIA IGE RIA Pharmacia, Inc. DGC Class II 1984-06-07
K841829 PHADEBAS RAST PHADEZYM RAST ALLERGEN Pharmacia, Inc. DGC Class II 1984-06-07
K842125 ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. DGC Class II 1984-06-07
K841642 MAST LUMINESCENT ALLERGY SYS Mast Immunosystems DGC Class II 1984-06-07
K841541 SERUM COMPLEMENT ACTIVITY TEST-SCAT Collaborative Research, Inc. DAK Class II 1984-06-01
K841815 OPTIMATE IGA TEST Miles Laboratories, Inc. CZN Class II 1984-06-01
K841651 VAST VENTREX RAST ALL Ventrex Laboratories, Inc. DGC Class II 1984-06-01
K841734 TAGO FIFFU-GEN, OROSOMUCOID Tago, Inc. LKL Class I 1984-06-01
K841925 DSL FERRITIN IRMA Diagnostic Systems Laboratories, Inc. DBF Class II 1984-05-25
K840221 EXTRACTABLE NUCLEAR ANTIGEN ASSAY Zeus Scientific, Inc. LLL Class II 1984-05-22
K841265 TAGO DIFFU-GEN C-REACTIVE PROTEIN Tago, Inc. DCN Class II 1984-05-22
K840476 PHADEXACT SERUM, TOTAL IGE CONTROLS Pharmacia, Inc. DGC Class II 1984-05-21
K840830 VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN Ventrex Laboratories, Inc. DER Class II 1984-05-21
K840867 ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN Intl. Diagnostic Technology DEI Class II 1984-05-11
K841516 VENTRESCREEN, MULTIPLE ALLERGEN DISCS Ventrex Laboratories, Inc. DHB Class II 1984-05-11
K841454 RF TEST KIT Difco Laboratories, Inc. DHR Class II 1984-04-25
K841127 VIRGO REAGENTS INDIRECT FLUORSCENT Electro-Nucleonics Laboratories, Inc. DHN Class II 1984-04-25
K840601 B2-MICRO CONTROL Pharmacia, Inc. JZG Class II 1984-04-20
K841146 NCS RA LATEX TEST Ncs Diagnostics, Inc. DHR Class II 1984-04-20
K834349 ANTI-NATIVE DNA ANTIBODY Sigma Chemical Co. KTL Class II 1984-04-19
K840670 PHADEBAS RAST PHADEZYM MIX ALLERG Pharmacia, Inc. DHB Class II 1984-04-18
K840876 PHADEBAS RAST TEST -ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1984-04-17
K840974 SOMAS HUMAN SPINAL FLUID CONTROL Somas Medical Industries, Inc. DFI Class I 1984-04-05
K840822 LEAP MONO TEST KIT Cooper Biomedical, Inc. KTN Class II 1984-04-05
K840863 SERATEST RF LATEX DETERMINATION Seragen Diagnostics, Inc. DHR Class II 1984-04-04
K834526 MAST INHALANT PROFILE Mast Immunosystems DHB Class II 1984-04-04
K834241 ANA APPLELISA Apple Diagnostic Products DHN Class II 1984-04-04
K840674 SENSIBEAD EIA IGE KIT Terumo Medical Corp. DGC Class II 1984-04-04
K840537 RAST ALLERGO SORBENT TEST Pharmacia, Inc. DHB Class II 1984-04-02
K840460 CORNINGS MAGIC FERRITIN RADIOIMMUNO- Corning Medical & Scientific JMG Class II 1984-03-30
K834070 IMMPULSE SYSTEM Paragon Diagnostics, Inc. JZT Class I 1984-03-23
K840538 PHADEXACT SERUM, ALLERGEN SPECIFIC IGE Pharmacia, Inc. DGC Class II 1984-03-23
K840699 CRP SLIDE TEST KIT Difco Laboratories, Inc. DCN Class II 1984-03-23
K833418 CHYMOFAST TEST Allergenetics DHB Class II 1984-03-12
K840360 ALLERCOAT MULTISCREEN DISCS Kallestad Laboratories, Inc. DHB Class II 1984-03-09
K840404 DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO Tago, Inc. DAD Class II 1984-03-09
K834584 NABI CRP-Q.S. TEST Intl. Diagnostic, Inc. DCN Class II 1984-02-27
K840005 NABI RF-Q.S. TEST Intl. Diagnostic, Inc. DHR Class II 1984-02-13
K834598 LIGHT TEST Hemogenetics, Inc. DHB Class II 1984-02-10
K834594 TOTAL IGE FAST TEST Allergenetics DGC Class II 1984-02-10
K840103 RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN Techniclone Intl. JHR Class II 1984-02-10
K834345 IM-CHECK Diagnostic Technology, Inc. KTN Class II 1984-02-10
K840049 SOPHEIA MP IGM RHEUMATOID FACTOR EIA Diagnostic Products Corp. DHR Class II 1984-02-10
K834390 IMMUNO-CRP Immunostics Co., Inc. DCN Class II 1984-02-03
K834391 IMMUNO-RA Immunostics Co., Inc. DHR Class II 1984-02-03
K833419 LABELED 125I ANTI-IGE Allergenetics DGC Class II 1984-02-03
K833402 TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN Technicon Instruments Corp. DEW Class II 1984-01-24
K834604 C3 ANTISERUM CONTROL Technicon Instruments Corp. CZW Class II 1984-01-24
K834605 C4 ANTIGEN ANTIBODY CONTROL Technicon Instruments Corp. DBI Class II 1984-01-24
K834140 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS Intl. Diagnostic Technology KTL Class II 1984-01-20
K833885 MAST INHALANT PROFILE Mast Immunosystems DHB Class II 1984-01-04
K833969 MAST TOTAL IGE Mast Immunosystems DGC Class II 1984-01-04
K833984 ANTINUCLEAR ANTIBODY IMMUNOLOGICAL Intl. Diagnostic Technology KTL Class II 1984-01-04
K833841 IL TEST IGG IGA & IGM KITS Instrumentation Laboratory CO CZK Class II 1984-01-04
K833318 NORMAL GOAT SERUM Biosan Laboratories, Inc. DHX Class II 1984-01-03
K832345 POLYSTYRENE MICROTITER WELL IMMUNOSOR Diagnostic Reagent Tech. DGC Class II 1983-11-25
K831984 POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE Diagnostic Reagent Tech. DGO Class II 1983-11-21
K833148 ENZYME ANA TEST SYSTEM Immuno Concepts, Inc. LJM Class II 1983-11-21
K833119 AUTOIMMUNE TEST 1/2/3 SYSTEM Atlantic Antibodies DHN Class II 1983-11-21
K832591 DIACROM *PLG Wellcome Diagnostics DDX Class I 1983-11-21
K832344 POLYSTYRENE MICROTITER PLATE IMMUNO- Diagnostic Reagent Tech. DHB Class II 1983-11-21
K832267 FITC GOAT ANTI-HUMAN LAMBA Gelco Diagnostics, Inc. DES Class II 1983-10-31
K832266 FITC GOAT ANTI-HUMAN KAPPA AFFINITY Gelco Diagnostics, Inc. DFH Class II 1983-10-31

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