meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
35
Latest Decision
1995-08-15

Clearances · page 19 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953261 CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM Shared Systems, Inc. DHR Class II 1995-08-15
K953014 ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN Diagnostic Products Corp. DHB Class II 1995-08-15
K953066 SERODIA ATG Fujirebio America, Inc. DDC Class II 1995-08-14
K952360 CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN Princeton BioMeditech Corp. DDR Class II 1995-08-14
K953207 HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION) The Binding Site, Ltd. DCK Class II 1995-08-01
K953197 EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) Johnson & Johnson Clinical Diagnostics, Inc. DCK Class II 1995-07-31
K953212 C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR Randox Laboratories, Ltd. DCK Class II 1995-07-31
K941398 EL-RF/3 (IGM-IGG-IGA) KIT Theratest Laboratories, Inc. DHR Class II 1995-07-28
K946034 QUANTA LITE(TM) IGG (HRP) Inova Diagnostics, Inc. MID Class II 1995-07-18
K951850 ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT Helix Diagnostics, Inc. LJM Class II 1995-07-18
K946385 QUANTA LITE ACA IGM (HRP) Inova Diagnostics, Inc. MID Class II 1995-07-18
K952055 ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY American Laboratory Products Co., Ltd. LRM Class II 1995-07-18
K952593 N/T PROTEIN CONTROL SY/L, M AND H Behring Diagnostics, Inc. DAD Class II 1995-07-17
K951798 ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT Helix Diagnostics, Inc. LJM Class II 1995-07-17
K952594 N PROTEIN STANDARD SY Behring Diagnostics, Inc. CZW Class II 1995-07-17
K951993 UBI MAGIWEL FERRITIN QUANTITATIVE United Biotech, Inc. DBF Class II 1995-07-05
K951487 DIASTAT ANTI-THYROID PEROXIDASE KIT Shield Diagnostics, Ltd. JZO Class II 1995-06-30
K952183 DIASTAT ANTI-THYROGLOBULIN KIT Shield Diagnostics, Ltd. JZO Class II 1995-06-30
K945884 SPECIFIC IGE ULTRA-EIA Hycor Biomedical, Inc. DHB Class II 1995-06-30
K952309 N LATEX IGA Behring Diagnostics, Inc. CZP Class II 1995-06-20
K944846 AURAFLEX B2-MICROGLOBULIN Organon Teknika Corp. JZG Class II 1995-06-20
K952130 ORGENTEC ANTI-TG ELISA American Laboratory Products Co., Ltd. JZO Class II 1995-06-20
K952286 AMERLITE FERRITIN II ASSAY Johnson & Johnson Clinical Diagnostics, Inc. DBF Class II 1995-06-20
K952129 ORGENTEC ANTI-TPO ELISA American Laboratory Products Co., Ltd. JZO Class II 1995-06-20
K945748 HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. DHB Class II 1995-06-07
K952077 HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-06-05
K952076 HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-06-05
K951966 HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. JZJ Class I 1995-06-01
K950979 HEP-2000 COLORZYME ANA-RO TEST SYSTEM Immuno Concepts, Inc. DHN Class II 1995-06-01
K951968 HUMAN C1Q RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. DAK Class II 1995-05-30
K951967 HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. DBA Class II 1995-05-30
K950629 ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR Bio-Rad Laboratories, Inc. DHB Class II 1995-05-23
K950393 ACE(TM) CEDIA(R) FERRITIN ASSAY Schiapparelli Biosystems, Inc. JMG Class II 1995-05-16
K950110 MARDX MITOCHONDRIA EIA TEST SYSTEM Hogan & Hartson LJM Class II 1995-05-15
K943686 IL TEST BETA-2MICROGLOBULIN Instrumentation Laboratory CO JZG Class II 1995-05-15
K951635 BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL Beckman Instruments, Inc. DEW Class II 1995-05-15
K946218 MARDX ENA EIA TEST SYSTEM Hogan & Hartson LJM Class II 1995-05-15
K950217 ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. JZO Class II 1995-04-24
K951101 LEUKO-TEST Techlab, Inc. DEG Class I 1995-04-24
K950089 ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. JZO Class II 1995-04-21
K950088 ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. JZO Class II 1995-04-21
K950090 ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. JZO Class II 1995-04-21
K931192 DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY Dako Corp. DEH Class II 1995-04-20
K951057 MAS LIQUID ASSAYED ALCOHOL/AMMONIA CONTROL LEVEL 1 AND 2 Medical Analysis Systems, Inc. DCK Class II 1995-04-20
K951055 OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. CFQ Class II 1995-04-17
K951186 VARELISA ANA-4 SCREEN Elias U.S.A., Inc. LJM Class II 1995-04-17
K951205 VARELISA ANA PROFILE Elias U.S.A., Inc. LJM Class II 1995-04-17
K943580 AUTOSTAT II ANTI-TPO Cogent Diagnotics , Ltd. JNL Class II 1995-04-17
K944334 VARELISA COMBINED DNA ANTIBODIES EIA Elias U.S.A., Inc. LRM Class II 1995-04-17
K951206 VARELISA PARIETAL CELL ANTIBODIES Elias U.S.A., Inc. MLE Class II 1995-04-17
K951207 VARELISA HISTONE ANTIBODIES Elias U.S.A., Inc. LJM Class II 1995-04-17
K951013 OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. CFQ Class II 1995-04-17
K950102 HUMAN C-5 RADIAL IMMUNODIFFUSION KIT Kent Laboratories, Inc. DAY Class II 1995-04-10
K950414 HEMAGEN ENA SM/RMP KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-03-29
K950707 N LATEX FERRITIN Behring Diagnostics, Inc. DBF Class II 1995-03-27
K950900 OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT Olympus America, Inc. CFQ Class II 1995-03-27
K931746 LATEX (K82) Diagnostic Products Corp. DHB Class II 1995-03-21
K941278 HY-TEC AUTOMATED EIA SYSTEM Hycor Biomedical, Inc. DHB Class II 1995-03-13
K950031 VARELISA DSDNA ANTIBODIES (FARR VERSION) Elias U.S.A., Inc. LRM Class II 1995-03-10
K945280 DUPONT DIMENSION C-REACTIVE PROTEIN METHOD Dupont Medical Products DCK Class II 1995-03-09
K933786 ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST Immco Diagnostics, Inc. MID Class II 1995-03-07
K933788 ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST Immco Diagnostics, Inc. MID Class II 1995-03-07
K933784 ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST) Immco Diagnostics, Inc. MID Class II 1995-03-07
K942813 DIASTAT ANTI-PR3 (C-ANCA) KIT Shield Diagnostics, Ltd. MOB Class II 1995-03-06
K943630 DIASTAT ANTI-MPO (PANCA) KIT Shield Diagnostics, Ltd. MOB Class II 1995-03-06
K943768 HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT Diagnostic Products Corp. DHB Class II 1995-03-06
K944192 ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER Light Diagnostics DBL Class II 1995-03-06
K944191 ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER Light Diagnostics DBL Class II 1995-03-06
K940037 I.D. AND SEAKEM GTG AGAROSES Fmc Corp. JZR Class I 1995-02-24
K943194 IMMULITE(R) ALLERGY FOOD PANEL FP5E Diagnostic Products Corp. DGO Class II 1995-02-23
K946121 HEMAGEN ENA SS-A KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-02-22
K946122 HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-02-22
K946120 HEMAGEN ENA SS-B KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-02-22
K946123 HEMAGEN ENA SM KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-02-22
K946124 HEMAGEN ENA JO-1 KIT (EIA METHOD) Hemagen Diagnostics, Inc. LLL Class II 1995-02-22
K946050 LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 Clinical Controls, Inc. DCK Class II 1995-02-10
K946048 LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 Clinical Controls, Inc. JZG Class II 1995-02-10
K946266 FERRITIN CONTROL - LEVEL 1, 2, 3 Clinical Controls, Inc. DGD Class II 1995-02-10
K942052 LIFESIGN MI MYOGLOBIN Princeton Biomedix DDR Class II 1995-02-07
K945607 VARELISA M2 ANTIBODIES Elias U.S.A., Inc. DBM Class II 1995-01-24
K942908 IGM RF EIA Sigma Diagnostics, Inc. DHR Class II 1995-01-20
K941057 SPECIFIC IGE EIA-ULTRA ASSAY Hycor Biomedical, Inc. DHB Class II 1995-01-20
K943585 ANTI-HISTONE ANIBODY TEST Immco Diagnostics, Inc. LJM Class II 1995-01-20
K944168 VARELISA LA (SS-B) ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K944169 VARELISA RO (SS-A) ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K944170 VARELISA SM ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K944172 VARELISA SCL-70 ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K944173 VARELISA JO-1 ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K943625 AUTOSTAT II ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd. DDC Class II 1994-12-22
K944171 VARELISA CENTROMERE ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K944167 VARELISA RNP-SM ANTIBODIES Elias U.S.A., Inc. LJM Class II 1994-12-22
K941564 IMMULITE ALATOP ALLERGY SCREEN Diagnostic Products Corp. DHB Class II 1994-12-19
K944876 HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT Research Diagnostics, Inc. DAS Class I 1994-12-15
K945522 I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS Beckman-Diagnostic Systems Group DFT Class II 1994-12-12
K943291 ANTI DS-DNA Sigma Diagnostics, Inc. LLL Class II 1994-12-02
K944505 DIASTAT ENA SINGLE WELL SCREEN KIT Shield Diagnostics, Ltd. LLL Class II 1994-11-21
K924804 DAKO MOUSE ANTI-HUMAN T-CELL Dako Corp. DEH Class II 1994-11-21
K944096 HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM Immuno Concepts, Inc. DHN Class II 1994-11-21
K943076 QUANTA LITE ENA 5 ELISA KIT Inova Diagnostics, Inc. LLL Class II 1994-10-25
K942328 N LATEX RF Behring Diagnostics, Inc. DHR Class II 1994-10-20

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