meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
38
Latest Decision
1991-07-30

Clearances · page 23 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K912291 DISTAT ANTI-SCL-70 KIT Shield Diagnostics, Ltd. LKJ Class II 1991-07-30
K912292 DIASTAT ANTI-JO-1 KIT Shield Diagnostics, Ltd. DHN Class II 1991-07-30
K912800 KALLESTEAD TOTAL IGE MICROPLATE KIT Bio-Rad Laboratories, Inc. DGC Class II 1991-07-25
K912940 COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA Diagnostic Products Corp. JZG Class II 1991-07-24
K905633 HUMAN C-REACTIVE PROTEIN RID KIT The Binding Site, Ltd. DCK Class II 1991-07-22
K910419 BIOCLONE'S ELEGANCE IGE ELISA KIT Bioclone Australia Pty , Ltd. DGC Class II 1991-06-21
K911610 ELISA COMBI-KIT HUMAN IGG SUBCLASSES Janssen Research Foundation DEW Class II 1991-06-12
K904310 RHEUMAGEN RF T-CONTROL Biokit USA, Inc. DHR Class II 1991-05-31
K910617 NATIVE PROTHROMBIN ANTIGEN EIA Organon Teknika Corp. DDF Class I 1991-05-15
K911899 RAICHEM SPIA C4 REAGENT Reagents Applications, Inc. DBI Class II 1991-05-09
K911900 RAICHEM SPIA C3 REAGENT Reagents Applications, Inc. CZW Class II 1991-05-09
K910553 ROCHE APOLIPOPROTEIN STANDARD Roche Diagnostic Systems, Inc. DER Class II 1991-05-08
K911898 RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT Reagents Applications, Inc. DAD Class II 1991-05-08
K911850 IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST General Biometrics, Inc. LKO Class II 1991-05-07
K911849 IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST General Biometrics, Inc. LKO Class II 1991-05-07
K911851 IMMUNOWELL SM ANTIBODY TEST General Biometrics, Inc. LKP Class II 1991-05-07
K911848 IMMUNOWELL RNP/SM ANTIBODY TEST General Biometrics, Inc. LKP Class II 1991-05-07
K911631 PHARMACIA SPECIFIC IGE CONTROL Pharmacia, Inc. DGC Class II 1991-04-24
K911511 ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED Diagnostic Products Corp. DGO Class II 1991-04-17
K894227 ALLERGEN MODULES FOR ALASTAT TM Diagnostic Products Corp. DHB Class II 1991-04-17
K910535 SYNCHRON C-REACTIVE PROTEIN REAGENT Beckman Instruments, Inc. DCN Class II 1991-04-12
K911175 SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE) Serono-Baker Diagnostics, Inc. DBF Class II 1991-04-05
K910539 RHEUMAJET RF Biokit USA, Inc. DHR Class II 1991-04-05
K910292 MAST CLA ALLERGY SYSTEM Mast Immunosystems DHB Class II 1991-04-05
K904254 NA ALPHA 1 MICROGLOBULIN KIT Behring Diagnostics, Inc. JZG Class II 1991-04-05
K905054 CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER Ciba Corning Diagnostics Corp. DHB Class II 1991-03-22
K910686 RHEUMAJET CRP Biokit USA, Inc. DCN Class II 1991-03-19
K910082 POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK Quidel Corp. DGC Class II 1991-03-12
K905770 CIBA CORNING ACS FERRITIN IMMUNOASSAY Ciba Corning Diagnostics Corp. DBF Class II 1991-03-12
K910052 MILENIA BETA-2 MICROGLOBULIN Diagnostic Products Corp. JZG Class II 1991-03-06
K910232 HEMAGEN ENA SCREENING KIT Hemagen Diagnostics, Inc. LLL Class II 1991-03-06
K910517 CAP SYSTEM RAST ASM/RIA AND ASM/FEIA Pharmacia, Inc. DHB Class II 1991-03-05
K905612 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY Ventrex Laboratories, Inc. DGC Class II 1991-02-21
K905636 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. DHB Class II 1991-02-07
K910075 SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE Diagnostic Products Corp. DHB Class II 1991-01-30
K905485 IMMUNOWELL THYROGLOBULIN TEST General Biometrics, Inc. JZO Class II 1991-01-25
K910033 UBI MAGIWEL(TM) ANA QUANTITATIVE United Biotech, Inc. LJM Class II 1991-01-25
K905162 QUIDEL TOTAL IGE POSITIVE CONTROL SERUM Quidel Corp. DHB Class II 1991-01-14
K905149 TITAN GEL Helena Laboratories DAH Class II 1991-01-03
K905486 IMMUNOWELL TPO (MICROSOME) TEST General Biometrics, Inc. JNL Class II 1991-01-03
K905386 DISTAT ANTI-DSDNA KIT Shield Diagnostics, Ltd. KTL Class II 1990-12-13
K905176 POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN Quidel Corp. DHB Class II 1990-12-13
K905193 DIASTAT ANTI-LA (SS-B) Shield Diagnostics, Ltd. LKO Class II 1990-12-13
K905202 TURBIQUANT MYOGLOBIN Behring Diagnostics, Inc. DDR Class II 1990-12-13
K905194 DIASTAT ANTI-RO (SS-A) Shield Diagnostics, Ltd. LKO Class II 1990-12-13
K904330 TURBO-RAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. DHB Class II 1990-12-07
K905191 DIASTAT ANTI-SM Shield Diagnostics, Ltd. LKP Class II 1990-12-07
K905192 DIASTAT ANTI-SM/RNP Shield Diagnostics, Ltd. LKP Class II 1990-12-07
K905190 DIASTAT ENA PROFILE Shield Diagnostics, Ltd. LJM Class II 1990-12-07
K904822 ELEGANCE FERRITIN ELISA Bioclone Australia Pty , Ltd. DBF Class II 1990-11-29
K904661 IVT RAST TRACER In Vitro Technologies, Inc. DHB Class II 1990-11-29
K904137 UC IMU B Eucardio Laboratory, Inc. DFC Class II 1990-11-21
K903637 ALRGN SET Ciba Corning Diagnostics Corp. DHB Class II 1990-11-21
K904175 RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT Reagents Applications, Inc. LKL Class I 1990-11-13
K904497 CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST Biotrax, Inc. DCN Class II 1990-11-01
K904498 CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST Biotrax, Inc. DHR Class II 1990-10-29
K903687 TURBIQUANT MYOGLOBIN Behring Diagnostics, Inc. DDR Class II 1990-10-16
K903742 ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE Diagnostic Products Corp. DHB Class II 1990-10-15
K904105 V-TREND TARGET RF TEST Texas Immunology, Inc. DHR Class II 1990-10-15
K903738 QUIDEL ALLERGEN SCREEN POSITIVE CONTROL Quidel Corp. DGC Class II 1990-10-15
K904224 NOVA LITE TM THYROID Inova Diagnostics, Inc. JZO Class II 1990-10-15
K903843 IMMUNODOT THYROID AUTOIMMUNITY PANEL General Biometrics, Inc. JNL Class II 1990-10-02
K904312 RHEUMAGEN CRP T-CONTROL Biokit USA, Inc. DCK Class II 1990-10-01
K903215 LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM Bioproducts For Science, Inc. JZG Class II 1990-09-25
K904125 UC IMU A Eucardio Laboratory, Inc. DER Class II 1990-09-24
K904038 MYOGLOBIN RIA TEST KIT Immuno Diagnostic Center, Inc. DDR Class II 1990-09-24
K902382 C3C AND C4 RID KITS The Binding Site, Ltd. CZW Class II 1990-09-07
K902915 ANTI-SCI-70 MICROASSAY Diamedix Corp. LJM Class II 1990-09-06
K903898 QUANTA LITE TM DSDNA Inova Diagnostics, Inc. LLL Class II 1990-09-05
K902220 PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL Boehringer Mannheim Corp. DGR Class I 1990-09-05
K902576 ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA Diagnostic Products Corp. DHB Class II 1990-09-04
K903852 RAPITEX(R) RF NEW Behring Diagnostics, Inc. DHR Class II 1990-08-30
K903853 RAPITEX (R) CRP NEW Behring Diagnostics, Inc. DCN Class II 1990-08-30
K896918 MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT Dako Corp. DEH Class II 1990-08-27
K903578 PHARMACIA DELFIA SYSTEM B2-MICRO Pharmacia, Inc. JZG Class II 1990-08-17
K903314 ANTI-SCI-70 ANTIBODY TEST Immco Diagnostics, Inc. LLL Class II 1990-08-14
K902938 IMMUNODOT AUTOIMMUNITY SCREENING PANEL 3 General Biometrics, Inc. LLL Class II 1990-08-09
K903047 IMMUMODOT AUTOIMMUNITY SCREENING PANEL 4 General Biometrics, Inc. LLL Class II 1990-08-09
K903195 LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY London Diagnostics, Inc. DGC Class II 1990-08-02
K902997 MILENIA (TM) FERRITIN Diagnostic Products Corp. JMG Class II 1990-08-02
K903122 EQUATE(TM) AQR APO AL/B DUO CONTROL Binax, Inc. DFC Class II 1990-08-02
K903000 TURBO-RAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. JHR Class II 1990-07-31
K902897 UBI MAGIWEL(TM) ANTI-DS-DNA QUANTITATIVE United Biotech, Inc. LRM Class II 1990-07-16
K902510 CARDS O.S. MONO Pacific Biotech, Inc. KTN Class II 1990-07-16
K902055 TENONE(TM) OPIATES CATALOG: VKSO1,4 Diagnostic Products Corp. DDE Class I 1990-07-10
K902237 MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT Medica Corp. DBL Class II 1990-07-09
K902593 RAICHEM(TM) SPIA(TM) CRP REAGENT Reagents Applications, Inc. DCN Class II 1990-06-28
K902541 MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX Trinity Laboratories, Inc. KTN Class II 1990-06-28
K902462 MODIFIED QM300 RHEUMATOID FACTOR TEST Kallestad Diag, A Div. of Erbamont, Inc. DHR Class II 1990-06-21
K902484 BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) Beckman Instruments, Inc. DFH Class II 1990-06-21
K902485 BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) Beckman Instruments, Inc. DEH Class II 1990-06-21
K761234 BEHRING LASER NEPHELOMETER Behring Diagnostics, Inc. JZW Class I 1990-06-07
K901805 REP(R) IMMUNOFIX Helena Laboratories DAH Class II 1990-06-06
K902154 NA LATEX MYOGLOBIN TEST Behring Diagnostics, Inc. DDR Class II 1990-06-01
K902139 HEMAGEN ENA [JO-I] KIT Hemagen Diagnostics, Inc. DHN Class II 1990-05-18
K901924 READS(R) ANTI-ENA (SM/RNP) TEST KIT Biosearch Medical Products, Inc. LLL Class II 1990-05-09
K901859 COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 Diagnostic Products Corp. JHR Class II 1990-05-03
K901596 NOVA LITE(TM) ANA KSL Inova Diagnostics, Inc. DHN Class II 1990-05-02
K901675 APOLIPOPROTEIN A-I (APO A-I) Sigma Chemical Co. DEL Class I 1990-04-26
K901595 NOVA LITE(TM) ANA MK Inova Diagnostics, Inc. DHN Class II 1990-04-26

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