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Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
51
Latest Decision
1979-03-15

Clearances · page 35 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K790257 SYSTEMIC LUPUS Icl Scientific DHC Class II 1979-03-15
K790106 IIF-A-N-DNA TEST KIT Medica Corp. DHC Class II 1979-03-15
K782129 LUPO-TEC Armkel, LLC DHC Class II 1979-03-12
K781951 ANTISERA, RHODAMINE CONJUGATED FRAGMENT Kallestad Laboratories, Inc. DCE Class I 1979-02-16
K782150 FLUROMETER, DADE Dade, Baxter Travenol Diagnostics, Inc. JZT Class I 1979-02-15
K781904 RIA KIT, QUANTITOPE IGE Kallestad Laboratories, Inc. DGC Class II 1979-02-08
K790012 RHEUMOGEN TEST SYSTEM Calbiochem-Behring Corp. DHR Class II 1979-01-26
K782157 IRMA TEST, NORDICLAB FERRITIN Nordiclab Intl. JMG Class II 1979-01-17
K782048 TEST KIT, IIF-ANA Medica Corp. DHN Class II 1979-01-17
K781844 FERRITIN KIT Ria Products, Inc. JMG Class II 1979-01-10
K781888 ASSAY SYSTEM, FERRITIN I KIT New England Nuclear JMG Class II 1979-01-10
K781946 RIA KIT, FERRITIN SOLID PHASE Bd Becton Dickinson Vacutainer Systems Preanalytic JMG Class II 1979-01-10
K782041 FIAX TEST KIT Idt, A Division of Whittaker M.A. Bioproducts DHN Class II 1979-01-03
K781478 PLASMINOGEN ASSAY Dade, Baxter Travenol Diagnostics, Inc. DDX Class I 1978-11-15
K781655 NEPHELRATE ANTISERUMS 1GA Antibodies, Inc. CFN Class II 1978-11-08
K781654 NEPHELRATE ANTIPERUMS LGM Antibodies, Inc. CFN Class II 1978-11-08
K781653 NEPHELRATE ANTISERUMS C3C Antibodies, Inc. CZW Class II 1978-11-08
K781656 NEPHELRATE ANTISERUMS, IGG Antibodies, Inc. CFN Class II 1978-11-08
K781527 RIA SYSTEM FOR HUMAN FE-RITIN Calbiochem-Behring Corp. JMG Class II 1978-10-03
K780899 FLUORESCENT ANTI-NATIVE DNA TEST Kallestad Laboratories, Inc. DHN Class II 1978-09-07
K781006 IMMUNOCHEMISTRY SYS. MANUAL MODE Beckman Instruments, Inc. JZW Class I 1978-08-31
K781355 ICS NORMAL CONTROL SERUM Beckman Instruments, Inc. DGR Class I 1978-08-31
K781408 RID SYSTEM-(ACP) TEST Icl Scientific DEM Class II 1978-08-21
K781023 ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU Icl Scientific DEX Class I 1978-08-14
K781015 ANTI-HUMAN LDL SERUM Icl Scientific DFC Class II 1978-08-14
K781016 C3PA (GBG) PROPERDIN FACTOR B Icl Scientific JZH Class II 1978-08-14
K781022 ANTI-HUMAN CIQ SERUM Icl Scientific DAK Class II 1978-08-14
K781017 ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) Icl Scientific DBA Class II 1978-08-14
K781024 CERUOPLASMIN SERUM ANTI-HUMAN Icl Scientific DDB Class II 1978-08-14
K781070 SECOND ANTIBODY Pcl-Ria, Inc. KTS Class II 1978-08-10
K781220 ANTI-HUMAN LAMBDA SERUM Icl Scientific DEH Class II 1978-07-27
K781027 KAPPA SERUM (FREE) ANTI-HUMAN Icl Scientific DFH Class II 1978-07-27
K781025 LAMBDA SERUM (FREE) ANTI-HUMAN Icl Scientific DEH Class II 1978-07-27
K781028 KAPPA SERUM (FREE & BOUND) ANTI-HUMAN Icl Scientific DFH Class II 1978-07-27
K780913 ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM Beckman Instruments, Inc. DCF Class II 1978-06-22
K780982 KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT Cis Radiopharmaceuticals, Inc. DDR Class II 1978-06-22
K780874 THYMUNE-T Burroughs Wellcome Co. DDC Class II 1978-06-14
K780873 THYMUNE-M Burroughs Wellcome Co. DDC Class II 1978-06-14
K780753 LAS-R HUMAN IGE TEST Hyland Therapeutic Div., Travenol Laboratories DGC Class II 1978-06-06
K780729 LAS-R HUMAN COMPLEMENT CLQ TEST Hyland Therapeutic Div., Travenol Laboratories DAK Class II 1978-05-18
K780490 NEIA-FERRITIN ENZYMEIMMUNOASSAY New England Immunology Assoc. DBF Class II 1978-04-10
K780335 LAS-R HUMAN C1 ESTERASE INHIBITOR TEST Hyland Therapeutic Div., Travenol Laboratories DBA Class II 1978-03-22
K780325 RID SYSTEM-HUMAN C-REACTIVE PROTEIN Icl Scientific DEN Class I 1978-03-17
K772327 LAS-R HUMAN IGD TEST Hyland Therapeutic Div., Travenol Laboratories CZJ Class II 1978-02-28
K780250 HEMOPEXIN NEPHELOMETRIC ASSAYS Kallestad Laboratories, Inc. CZX Class II 1978-02-28
K780178 TEST SYS. FOR NDNA ANTIBODY DETERM. Zeus Scientific, Inc. DHN Class II 1978-02-13
K780161 IMMUNOPEROXIDASE TEST SYS. FOR ANA SETER Zeus Scientific, Inc. DHN Class II 1978-02-07
K772073 RADIAL IMMUNODIFFUSION KIT-COMP. 3 Gelman Instrument Co. DBI Class II 1978-02-03
K772074 RADIAL IMMUNODIFFUSION KIT-TRANSFERRIN Gelman Instrument Co. DDI Class II 1978-02-03
K772080 RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT Gelman Instrument Co. DEM Class II 1978-02-03
K772075 RADIAL IMMUNODIFFUSION KIT-COMPLEMENT Gelman Instrument Co. DAY Class II 1978-02-03
K772076 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. Gelman Instrument Co. CZP Class II 1978-02-03
K772078 RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN Gelman Instrument Co. DAB Class II 1978-02-03
K772077 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G Gelman Instrument Co. DEW Class II 1978-02-03
K772329 LAS-R HUMAN PREALBUMIN TEST Hyland Therapeutic Div., Travenol Laboratories JZJ Class I 1978-02-03
K772079 RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M Gelman Instrument Co. DFL Class II 1978-02-03
K772085 LAS-R HUMAN PLASMINOGEN TEST Hyland Therapeutic Div., Travenol Laboratories DDX Class I 1978-01-24
K772084 LAS-R HUMAN C3 PROACTIVATOR TEST Hyland Therapeutic Div., Travenol Laboratories JZH Class II 1978-01-24
K772219 FIAX TEST FOR ANTI-RUBELLA ANTIBODY Idt, A Division of Whittaker M.A. Bioproducts DHN Class II 1978-01-20
K772345 FLUORESCEIN CONJUG. FRACT. MONO. ANTI. Kallestad Laboratories, Inc. DCB Class I 1978-01-05
K772095 HEMAGGLUTINATION INHIBITION TEST Miles Laboratories, Inc. DDR Class II 1978-01-05
K772255 CERULOPLASMIN NEPHEL. ASSAY Kallestad Laboratories, Inc. DDB Class II 1978-01-05
K772247 COMPLEMENT C4 NEPHELOMETRIC ASSAY Kallestad Laboratories, Inc. DBI Class II 1977-12-22
K772246 ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY Kallestad Laboratories, Inc. DEB Class II 1977-12-22
K772250 ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY Kallestad Laboratories, Inc. DEI Class II 1977-12-22
K772245 HAPTOGLOBIN NEPHELOMETRIC ASSAY Kallestad Laboratories, Inc. DAD Class II 1977-12-22
K772252 IMMUNOGLOBULIN G NEPHEL. ASSAY Kallestad Laboratories, Inc. DEW Class II 1977-12-22
K772254 IMMUNOGLOBULIN M NEPHEL. ASSAY Kallestad Laboratories, Inc. DFT Class II 1977-12-22
K772253 TRANSFERRIN NEPHELOMETRIC ASSAY Kallestad Laboratories, Inc. DDG Class II 1977-12-22
K772251 IMMUNOGLOBULIN A NEPHEL. ASSAY Kallestad Laboratories, Inc. CZP Class II 1977-12-22
K772114 FIAX C4 ASSAY Idt, A Division of Whittaker M.A. Bioproducts DAK Class II 1977-11-30
K772128 FLUORESCEIN CONJUGATED Kallestad Laboratories, Inc. DCE Class I 1977-11-22
K771795 LAS-R CERULOPLASMIN TEST Hyland Therapeutic Div., Travenol Laboratories DDB Class II 1977-11-14
K772003 HUMAN REFERENCE SERUM C4 COMPLEMENT G.D. Searle and Co. DAK Class II 1977-11-03
K772004 HUMAN C4 COMPLEMENT CONTROL SERUM G.D. Searle and Co. DBI Class II 1977-11-03
K772002 PLATES FOR HUMAN C4 COMPLEMENT G.D. Searle and Co. DBI Class II 1977-11-02
K771940 QUANTROLS RF Organon, Inc. DHR Class II 1977-11-02
K771993 AFT SYSTEM Calbiochem DBM Class II 1977-11-02
K771879 GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID Hyland Therapeutic Div., Travenol Laboratories DEN Class I 1977-10-19
K771912 LAS-R BETA LIPOPROTEIN TEST Hyland Therapeutic Div., Travenol Laboratories DFC Class II 1977-10-19
K771812 LIPPOPROTEIN ELECTROPHORESIS REAGENT SET Gelman Instrument Co. DFC Class II 1977-10-18
K771376 IFA ANTI-NDNA Electro-Nucleonics Laboratories, Inc. DHN Class II 1977-10-18
K771771 QUAN. COLOR. DETER. OF SERUM ALBUMIN Stanbio Laboratory DCF Class II 1977-10-07
K771768 GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM G.D. Searle and Co. DEH Class II 1977-10-07
K771780 LAS-R TM Hyland Therapeutic Div., Travenol Laboratories DEB Class II 1977-10-04
K771603 IMMOCHEMISTRY SYSTEM Beckman Instruments, Inc. CZP Class II 1977-09-15
K771410 RHEUMANOSTICON R Organon, Inc. DHR Class II 1977-09-02
K771535 LAS-R HUMAN CRP TEST Hyland Therapeutic Div., Travenol Laboratories DCN Class II 1977-09-02
K771578 PHADEBAS RAST PENICLLOYL G/V TEST Pharmacia, Inc. DHB Class II 1977-09-02
K771583 FLUORESCENT ANTI. ANTI-HUMAN C3 Burroughs Wellcome Co. DAC Class II 1977-09-02
K771552 LAS-R RHEUMATOID FACTOR TEST Hyland Therapeutic Div., Travenol Laboratories DHR Class II 1977-08-30
K771397 MONOSTICON TEST Organon, Inc. KTN Class II 1977-08-22
K771155 ANTI-MITOCHONDRIAL Meloy Laboratories, Inc. DBE Class II 1977-08-04
K771242 ANTISERA TO HUMAN FAB FRAGMENT Kent Laboratories, Inc. DDR Class II 1977-08-03
K771243 ANTISERA TO HUMAN FAB FRAGMENT Kent Laboratories, Inc. DFK Class I 1977-08-03
K771226 LAS-R TEST PROGRAM Hyland Therapeutic Div., Travenol Laboratories CFN Class II 1977-07-21
K771238 RID PLATES & INTENSI. FOR HUMAN IGE ETC G.D. Searle and Co. DGC Class II 1977-07-15
K771144 RHODAMINE-CONJUGATED ANTISERUM Kent Laboratories, Inc. DBY Class I 1977-07-14
K771139 CRP-WELLCOTEST Burroughs Wellcome Co. DCN Class II 1977-07-14
K770963 GOAT ANTISERUM IGM NEPHELOMHTRIC Kallestad Laboratories, Inc. DFT Class II 1977-06-24

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