meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
35
Latest Decision
1990-04-26

Clearances · page 24 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K900943 MODIFIED TECHNICON DPA-1(TM) SYSTEM Technicon Instruments Corp. DEW Class II 1990-04-26
K901453 QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD Isolab, Inc. DFT Class II 1990-04-12
K901075 LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. London Diagnostics, Inc. DBF Class II 1990-04-02
K901333 BETA-2 MICROGLOBULIN EIA Serex, Inc. JZG Class II 1990-04-02
K901230 REAADS ANTI-SM TEST KIT Biosearch Medical Products, Inc. LLL Class II 1990-03-23
K901073 ANTI-RNP MICROASSAY Diamedix Corp. LLL Class II 1990-03-19
K900875 RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT Reagents Applications, Inc. DDG Class II 1990-03-06
K900124 APOLIPOPROTEIN B (APO B) Sigma Chemical Co. DEL Class I 1990-03-02
K900422 TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 Helena Laboratories CZP Class II 1990-02-27
K900625 MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET Armkel, LLC KTN Class II 1990-02-26
K900440 AIA-PACK BMG Tosoh Medics, Inc. JZG Class II 1990-02-26
K900617 SERATEST ENA [SSA] KIT Hemagen Diagnostics, Inc. LLL Class II 1990-02-23
K900244 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 3M Company DGC Class II 1990-02-21
K900108 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 3M Company DGC Class II 1990-02-21
K900449 PHARMACIA B2 MICRO EIA Pharmacia, Inc. JZG Class II 1990-02-05
K900241 ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY Diamedix Corp. LLL Class II 1990-02-02
K896926 DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS Quidel Corp. KTN Class II 1990-01-26
K900072 IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 General Biometrics, Inc. LJM Class II 1990-01-24
K900167 TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT Behring Diagnostics, Inc. DCF Class II 1990-01-22
K894190 PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA Pharmacia, Inc. DHB Class II 1990-01-22
K900107 LD-1 Boehringer Mannheim Corp. DET Class I 1990-01-18
K897145 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) 3M Company DHB Class II 1990-01-10
K896902 ENZYMUN TEST R IGE Boehringer Mannheim Corp. DHB Class II 1990-01-10
K897025 ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM Zeus Scientific, Inc. DHN Class II 1990-01-02
K896852 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY Ventrex Laboratories, Inc. DHB Class II 1989-12-18
K896694 VENTREZYME VAST SPECIFIC IGE ASSAY Ventrex Laboratories, Inc. DHB Class II 1989-12-08
K896347 IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 General Biometrics, Inc. LJM Class II 1989-12-05
K896585 MODIFIED FERRITIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. DBF Class II 1989-12-04
K896592 CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY Ciba Corning Diagnostics Corp. DHB Class II 1989-12-04
K896483 QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DEB Class II 1989-12-01
K896459 NOVA GEL(TM) T SM/RNP Inova Diagnostics, Inc. LLL Class II 1989-11-20
K896460 NOVA GEL(TM) T SS-A/SS-B Inova Diagnostics, Inc. LLL Class II 1989-11-20
K896461 NOVA GEL(TM) T SCL-70 Inova Diagnostics, Inc. LLL Class II 1989-11-20
K896462 NOVA GEL(TM) T JO-1 Inova Diagnostics, Inc. LLL Class II 1989-11-20
K895914 ABBOTT IMX IGE Abbott Laboratories DGC Class II 1989-11-13
K896271 QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) Biokit USA, Inc. DHR Class II 1989-11-08
K896272 QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL Biokit USA, Inc. DCN Class II 1989-11-08
K895600 HUMAN (IGG) SUBCLASS (EIA) KIT The Binding Site, Ltd. DAS Class I 1989-11-08
K896059 MODIFIED QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DCF Class II 1989-11-06
K895996 RHEUMELISA ASSAY FOR SM AUTOANTIBODIES Lipogen, Inc. LKP Class II 1989-11-06
K895997 RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES Lipogen, Inc. LKO Class II 1989-11-06
K895765 LEECO PREVIEW(R) EBV (EIA) Leeco Diagnostics, Inc. KTN Class II 1989-10-31
K895891 DETECTADOT SYSTEM 2000 HETEROPHILE TEST Gull Laboratories, Inc. KTN Class II 1989-10-31
K895995 RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES Lipogen, Inc. LJM Class II 1989-10-27
K895994 RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES Lipogen, Inc. LJM Class II 1989-10-24
K895808 TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN Technicon Instruments Corp. DCF Class II 1989-10-17
K895338 ANTI-RNP AND ANTI-SM ANTIBODY TEST Immco Diagnostics, Inc. LKO Class II 1989-10-17
K895872 LAN.0800Q/2800Q Amersham Corp. DBF Class II 1989-10-17
K895496 BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA Incstar Corp. JZG Class II 1989-10-17
K895160 ORTHO *APO A-1 ELISA TEST SYSTEM Medical Marketing Consultants, Inc. DEL Class I 1989-10-06
K895339 ANTI-SS-A (RO) AND ANTI-SS-B (LA) ANTIBODY TEST Immco Diagnostics, Inc. LLL Class II 1989-10-04
K895004 MILENIA(TM) TOTAL IGE (MKIE1,5) Diagnostic Products Corp. DGC Class II 1989-09-28
K895598 WAKO(TM) AUTOKIT CRP Wako Chemicals USA, Inc. DCK Class II 1989-09-27
K895377 QM300 CERULOPLASMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DDB Class II 1989-09-21
K894659 ANA ANTISERA CONTROL KIT Lipogen, Inc. DHN Class II 1989-09-21
K895294 PROGENE IGE BEAD EIA Progene Corp. DGC Class II 1989-09-21
K894975 IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST General Biometrics, Inc. KTN Class II 1989-09-13
K890689 ADX TM OPIATES Abbott Laboratories DGJ Class I 1989-08-25
K894894 ANTI-SM MICROASSAY Diamedix Corp. LJM Class II 1989-08-24
K894793 MONODEX Cenogenics Corp. KTN Class II 1989-08-21
K894573 SCANLISA HUMAN CRP ELISA KIT Immuntech A/S DCK Class II 1989-08-10
K894574 TECHNICON DPA-1 SYSTEM RF METHOD Technicon Instruments Corp. DHR Class II 1989-08-10
K894538 QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DBN Class I 1989-08-04
K893419 COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) Coulter Immunology DEW Class II 1989-08-03
K894411 SERATEST ENA [SCL-70] KIT Hemagen Diagnostics, Inc. LKJ Class II 1989-08-02
K894417 RAICHEM(TM) SPIA(TM) IGM REAGENTS Reagents Applications, Inc. DFT Class II 1989-08-02
K894418 RAICHEM(TM) SPIA(TM) IGA REAGENTS Reagents Applications, Inc. CZP Class II 1989-08-02
K894416 RAICHEM(TM) SPIA(TM) IGG REAGENTS Reagents Applications, Inc. KTO Class I 1989-08-01
K894253 QUIDEL FOOD ALLERGEN SCREEN Quidel Corp. DHB Class II 1989-07-28
K894203 ANTI-THYROGLOBULIN TEST KIT Kronus JZO Class II 1989-07-25
K894364 MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) Kronus JZO Class II 1989-07-25
K894039 QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION Quidel Corp. DGO Class II 1989-07-14
K893896 QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA Biostar Medical Products, Inc. LKJ Class II 1989-07-14
K893951 PHARMACIA CAP SYSTEM IGE RIA AND FEIA Pharmacia, Inc. DGC Class II 1989-07-14
K893897 SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM Biostar Medical Products, Inc. LKJ Class II 1989-06-23
K893885 BACTON TM, BASIC TM, APO A-I REAGENT Catachem, Inc. DEL Class I 1989-06-21
K893737 DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST Quidel Corp. KTN Class II 1989-06-16
K893125 BECKMAN EPSILON(TM) IGE REAGENT KIT Beckman Instruments, Inc. DGO Class II 1989-06-16
K892424 REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 Helena Laboratories CFF Class II 1989-06-09
K892445 REAADS-RF TEST KIT-SEMIQUANTITATIVE Biosearch Medical Products, Inc. DHR Class II 1989-06-05
K892444 REAADS-RF TEST KIT-QUANTITATIVE Biosearch Medical Products, Inc. DHR Class II 1989-06-05
K892197 ALATOP (TM) CATALOG # AKAL1 Diagnostic Products Corp. DGC Class II 1989-06-02
K893132 PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC Pharmacia, Inc. DHB Class II 1989-06-02
K893036 ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) Amersham Corp. LRM Class II 1989-06-02
K892897 NOVA GEL(TM) JO-1 Inova Diagnostics, Inc. LLL Class II 1989-05-17
K892198 TECHNICON DPA-1 (TM) CRP METHOD Technicon Instruments Corp. DCK Class II 1989-05-09
K892526 SPQ TM TEST SYSTEM II FOR CRP Atlantic Antibodies DCK Class II 1989-05-09
K891135 PHADIATOP PAEDIATRIC RIA AND EIA Pharmacia, Inc. DHB Class II 1989-05-09
K892421 MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST Lipogen, Inc. LJM Class II 1989-05-09
K892362 AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) Amersham Corp. DBF Class II 1989-05-09
K892223 BEHRING NEPHELOMETER 100 Behring Diagnostics, Inc. JZW Class I 1989-05-04
K892409 QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN Quidel Corp. DHB Class II 1989-05-04
K891093 ACA (R) DIGITOXIN CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. DCJ Class I 1989-04-26
K892231 V-TREND TARGET CRP TEST Texas Immunology, Inc. DCN Class II 1989-04-21
K891385 VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) Vitek Systems, Inc. DEW Class II 1989-04-18
K892127 EZ COMPLEMENT C3 Diamedix Corp. CZW Class II 1989-04-14
K892119 QUIK-DOT C REACTIVE PROTEIN Ampcor, Inc. DCK Class II 1989-04-14
K892146 C REACTIVE PROTEIN LIQUID Ampcor, Inc. DCK Class II 1989-04-14
K885224 ANA-5 AUTOANTIBODY PROFILE KIT Autoimmunity Diagnostics Corp. LKJ Class II 1989-04-14
K891904 EZ COMPLEMENT C1 Diamedix Corp. DAC Class II 1989-04-14

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