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Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
44
Latest Decision
1980-06-30

Clearances · page 34 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K801361 COMPLEMENT C4 NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. DBI Class II 1980-06-30
K801283 J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. CZP Class II 1980-06-30
K801363 COMPLEMENT C3 NEPHELOMETRIC ASSAY J.T. Baker Chemical Co. CZW Class II 1980-06-30
K801281 J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI J.T. Baker Chemical Co. DEW Class II 1980-06-20
K800698 AUTOFLUOR SYSTEM California Immuno Diagnostic, Inc. JZT Class I 1980-05-28
K801019 125I-IGE RADIOIMMUNOASSAY KIT Bio-Ria DGC Class II 1980-05-20
K800995 IMMUNOGLOBULIN E TEST KIT Calbiochem-Behring Corp. DGO Class II 1980-05-14
K801046 ANATON Armkel, LLC DHN Class II 1980-05-14
K800992 CORDIA NP Cordis Corp. DHC Class II 1980-05-08
K800991 CORDIA N Cordis Corp. DHC Class II 1980-05-08
K800897 RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. Icl Scientific DEW Class II 1980-05-08
K800820 AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY Calbiochem-Behring Corp. DBE Class II 1980-04-24
K800450 GEMENI IGM ASSAY Electro-Nucleonics Laboratories, Inc. DAO Class II 1980-04-24
K800451 GEMENI IGG ASSAY Electro-Nucleonics Laboratories, Inc. DEW Class II 1980-04-24
K800821 AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY Calbiochem-Behring Corp. DBM Class II 1980-04-24
K800657 FERRITIN CONTROLS CODE QAS.104 Amersham Corp. DBF Class II 1980-04-16
K800605 ANA LATEX SLIDE TEST Biologics Intl., Inc. DHC Class II 1980-04-02
K800398 PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT Diagnostica, Inc. DEW Class II 1980-03-12
K800449 GEMENI IGA ASSAY Electro-Nucleonics Laboratories, Inc. CZP Class II 1980-03-12
K800299 FERRITIN RIA KIT Amersham Corp. DBF Class II 1980-03-03
K792610 KALLESTAD FLORESCENT ANA/AMA/ASMA TEST Kallestad Laboratories, Inc. DBL Class II 1980-02-22
K800268 AUTOMATED RHEMATOID FACTOR TEST (ARFT) Bd Becton Dickinson Vacutainer Systems Preanalytic DHR Class II 1980-02-21
K800228 IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT Clinical Sciences, Inc. DBE Class II 1980-02-21
K800229 IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT Clinical Sciences, Inc. DBM Class II 1980-02-21
K800212 COMPLEMENT C3 REAGENT SYSTEM Calbiochem-Behring Corp. CZW Class II 1980-02-19
K800211 IMMUNOGLOBULIN A REAGENT SYSTEM Calbiochem-Behring Corp. CZP Class II 1980-02-19
K800167 IMMUNOGLOBULIN M REAGENT SYSTEM Calbiochem-Behring Corp. DFT Class II 1980-02-05
K800119 IMMUNOGLOBULIN G REAGENT SYSTEM Calbiochem-Behring Corp. DEW Class II 1980-02-05
K792695 ANTI-GLOBULIN CONTROL Meridian Diagnostics, Inc. DHR Class II 1980-01-24
K792699 OUCHTERLONY AGAR PLATES Meridian Diagnostics, Inc. JZQ Class I 1980-01-24
K792697 NORMAL GLOBULIN REAGENT Meridian Diagnostics, Inc. DHR Class II 1980-01-24
K791996 MULTIPLE AUTO ANTIBODY TEST Meda Stat Diagnostics, Inc. DBL Class II 1980-01-16
K792636 CENTRIA RADIOIMMUNOASSAY SEPARATION Union Carbide Corp. KTS Class II 1980-01-11
K792637 CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) Union Carbide Corp. KTS Class II 1980-01-11
K792588 TERRITIN RIA KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JMG Class II 1980-01-11
K791458 AGGLUTINOTEST-THYROGLOBULIN Volu Sol Medical Industries JZO Class II 1979-12-31
K791455 AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS Volu Sol Medical Industries KTN Class II 1979-12-31
K791461 AGGLUTINOTEST-C-REACTIVE PROTEIN Volu Sol Medical Industries DCK Class II 1979-12-31
K792449 CENTRIA FERRITIN RIA Union Carbide Corp. DBF Class II 1979-12-31
K791507 AGGLUTINOTEST-RHEUMATOID ARTHRITIS Volu Sol Medical Industries DHR Class II 1979-12-31
K792472 ELECTRO-IMMUNO-QUANTITATION (EIQ) Icl Scientific DAK Class II 1979-12-27
K792442 FERRITIN RADIOIMMUNOASSAY Dade, Baxter Travenol Diagnostics, Inc. DBF Class II 1979-12-18
K791860 FERRITIN RIA KIT Cis Radiopharmaceuticals, Inc. DBF Class II 1979-12-06
K792238 CRPTELL Central Biological Co. DCK Class II 1979-11-30
K792184 LAB-TEK ANA TEST KIT Miles Laboratories, Inc. DHN Class II 1979-11-30
K791281 ANTI-HUMAN IGG SERUM Diagnostica, Inc. DEW Class II 1979-11-27
K791283 ANTI-HUMAN LAMBDA SERUM Diagnostica, Inc. DEH Class II 1979-11-27
K792061 CORDIA RF Cordis Corp. DHR Class II 1979-11-27
K791284 ANTI-HUMAN KAPPA SERUM Diagnostica, Inc. DFH Class II 1979-11-27
K792014 LANCER L-INA BUFFER, POLYMER, WASH SOLU Sherwood Medical Industries JZW Class I 1979-11-13
K791928 ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT Keith E. Abbott DHN Class II 1979-11-13
K791995 ANTI NUCLEAR ANTIBODY TEST Meda Stat Diagnostics, Inc. DHN Class II 1979-10-30
K791402 LANCER L-INA ANTI-IGM Sherwood Medical Co. DFT Class II 1979-10-17
K791404 LANCER L-INA ANTI-C3 Sherwood Medical Co. CZW Class II 1979-10-17
K791824 ANTISERUM TO HUMAN IMMUNOGLOBULINS Icl Scientific DEW Class II 1979-10-17
K791285 ANTI-HUMAN GLOBULINS Diagnostica, Inc. DEW Class II 1979-10-17
K791401 LANCER L-INA ANTI-IGA Sherwood Medical Co. CZP Class II 1979-10-17
K791403 LANCER L-INA ANTI-IGG Sherwood Medical Co. DEW Class II 1979-10-17
K791282 ANTI-HUMAN SERUM Diagnostica, Inc. DGQ Class I 1979-10-17
K791749 INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL Clinical Sciences, Inc. DAA Class II 1979-10-17
K791493 ANTI-NUCLEAR ANTIBODY TEST Meloy Laboratories, Inc. DHN Class II 1979-09-24
K791560 GOAT ANTI-HUMAN C-REACTIVE PROTEIN Protos Laboratories DCK Class II 1979-09-24
K791650 HUMAN, C-REACTIVE PROTEIN (CRP) Beckman Instruments, Inc. DCK Class II 1979-09-17
K791354 CODE QAS 103 ANTI-DNA CONTROLS Amersham Corp. KTL Class II 1979-09-17
K790706 ANTISERUM TO RABBIT IGG H & L CHAIN Kent Laboratories, Inc. DFH Class II 1979-09-12
K790713 ANTISERUM TO HUMAN HEMOPEXIN Kent Laboratories, Inc. CZX Class II 1979-09-04
K791605 GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN Protos Laboratories DEM Class II 1979-09-04
K790702 ANTISERUM, HUMAN, IGG H & L CHAIN Kent Laboratories, Inc. DEW Class II 1979-09-04
K790711 ANTISERA TO HUMAN FRAGMENT Kent Laboratories, Inc. DFK Class I 1979-09-04
K790708 ANTISERUM TO HUMAN IG G FC FRAGMENTS Kent Laboratories, Inc. DAS Class I 1979-08-22
K790715 ANTISERUM TO HUMAN FC Kent Laboratories, Inc. DAS Class I 1979-08-16
K790720 ANTISERA TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. DFZ Class II 1979-08-16
K791339 HUMAN CERULOPLASMIN Beckman Instruments, Inc. DDB Class II 1979-08-16
K790712 ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI Kent Laboratories, Inc. DDB Class II 1979-08-16
K790709 ANTISERUM TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. DFZ Class II 1979-08-16
K791340 HUMAN ALPHA2 MACROGLOBULIN Beckman Instruments, Inc. DEB Class II 1979-08-16
K791341 HUMAN ALPHA, ACID GLYCOPROTEIN Beckman Instruments, Inc. DEX Class I 1979-08-16
K790714 ANTISERUM TO HUMAN CERULOPLASMIN Kent Laboratories, Inc. DDB Class II 1979-08-16
K790716 ANTISERUM TO HUMAN C-REACTIVE PROTEINS Kent Laboratories, Inc. DCN Class II 1979-08-03
K791117 RABBIT COMPLEMENT Calbiochem-Behring Corp. KTQ Class I 1979-08-03
K790710 ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN Kent Laboratories, Inc. DDY Class II 1979-08-03
K791115 GOAR ANTI-HUMAN LAMBODA CHAIN Protos Laboratories DEH Class II 1979-08-03
K791096 RADIOIMMUNOASSAY TEST SYSTEM Corning Medical & Scientific JMG Class II 1979-08-03
K790759 IIF-APCA TEST KIT Medica Corp. DBJ Class II 1979-07-30
K790667 CORNING PARAPROTEIN SCREENING Corning Medical & Scientific CFF Class II 1979-07-24
K790295 TEST KIT, IIF-AMA Medica Corp. DBM Class II 1979-05-25
K790646 HELENA QUIPLATE SYSTEM Helena Laboratories JZQ Class I 1979-05-23
K790490 NEIA-FERRITIN ENZYMEIMMUNASSAY KIT New England Immunology Assoc. DBF Class II 1979-04-23
K790447 VENTRE/SEP FERRITIN RIA Ventrex Laboratories, Inc. DBF Class II 1979-04-23
K790280 AUTOANTIBODY REAGENTS, AFT SYSTEM II Calbiochem-Behring Corp. DHN Class II 1979-04-23
K790430 MEDICA II-F-ASMA TEST KIT Medica Corp. DBE Class II 1979-04-23
K790703 ANTISERUM, HUMAN, IGA Kent Laboratories, Inc. CZP Class II 1979-04-12
K790705 ANTISERUM TO HUMAN IGM Kent Laboratories, Inc. DAO Class II 1979-04-12
K790704 ANTISERUM TO HUMAN IGG Kent Laboratories, Inc. DEW Class II 1979-04-12
K790298 RADIOASSAY, CONTROL SERUM I, II, III Kallestad Laboratories, Inc. DGR Class I 1979-04-04
K790479 A-GENT IMMUNOGLOBULINE TEST SYSTEM Abbott Laboratories CZP Class II 1979-04-03
K790380 LOW-TOX-H RABBIT COMPLEMENT Cederlane Labs , Ltd. KTQ Class I 1979-03-21
K790252 ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI Meloy Laboratories, Inc. DHN Class II 1979-03-15
K790351 RHEUMATELL Central Biological Co. DHR Class II 1979-03-15
K790059 PROACTIVATOR C3, C4 AND C3 Icl Scientific KTP Class II 1979-03-15

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