Review Panel
Immunology FDA 510(k) Clearances & Devices
- Cleared Devices
- 3,548
- Product Codes (page)
- 39
- Latest Decision
- 2000-08-30
Clearances · page 12 of 36
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K002313 | COMPLEXED PSA MICROTITER ELISA | Oncogene Science, Inc. | LTJ | Class II | 2000-08-30 |
| K002121 | TOTAL PSA MICROTITER ELISA | Oncogene Science, Inc. | LTJ | Class II | 2000-08-30 |
| K001127 | ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | MOB | Class II | 2000-08-30 |
| K001636 | C-REACTIVE PROTEIN ANTISERUM KIT | The Binding Site, Ltd. | DCK | Class II | 2000-08-24 |
| K001556 | HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY | The Binding Site, Ltd. | DHN | Class II | 2000-08-21 |
| K001981 | DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500 | Axis-Shield , Ltd. | MID | Class II | 2000-08-21 |
| DEN000007 | QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA | Inova Diagnostics, Inc. | NBT | Class II | 2000-08-16 |
| K002107 | IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. | Scimedx Corp. | MVM | Class II | 2000-08-04 |
| K001009 | RANDOX C-REACTIVE PROTEIN | Randox Laboratories, Ltd. | DCK | Class II | 2000-08-04 |
| K001934 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-24 |
| K001931 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-24 |
| K001933 | WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-24 |
| K001929 | WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-24 |
| K001920 | WAKO AUTOKIT LP(A)/ RA,500/1000, | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-23 |
| K001919 | WAKO AUTOKIT LP(A)/DADE DEMENSION | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-23 |
| K001921 | WAKO AUTOKIT LP(A)/EXPRESS 550 | Wako Chemicals USA, Inc. | DFC | Class II | 2000-07-23 |
| K994419 | FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM | Qualisys Diagnostics, Inc. | LTJ | Class II | 2000-06-28 |
| K000336 | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E | Rhigene, Inc. | NBO | Class II | 2000-06-09 |
| K001574 | DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600 | Axis-Shield | MID | Class II | 2000-06-09 |
| K001393 | THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR | Zeus Scientific, Inc. | MST | Class II | 2000-06-07 |
| K000535 | QUANTA LITE LKM-1 ELISA | Inova Diagnostics, Inc. | NBS | Class II | 2000-06-07 |
| K000880 | THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | LJM | Class II | 2000-05-22 |
| K000879 | THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | LJM | Class II | 2000-05-22 |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | DER | Class II | 2000-05-18 |
| K000121 | IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB | Beckman Coulter, Inc. | DFC | Class II | 2000-05-17 |
| K000155 | ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM | Roche Diagnostics Corp. | JZO | Class II | 2000-05-17 |
| K000750 | RHIGENE MESACUP2 TEST- SCL-70 | Rhigene, Inc. | LLL | Class II | 2000-05-09 |
| K994140 | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 | Nichols Institute Diagnostics | MSW | Class II | 2000-05-09 |
| K000749 | RHIGENE MESACUP2 TEST- SSA | Rhigene, Inc. | LLL | Class II | 2000-05-09 |
| K000755 | RHIGENE MESACUP2 TEST- SM | Rhigene, Inc. | LKP | Class II | 2000-05-09 |
| K000751 | RHIGENE MESACUP2 TEST- SSB | Rhigene, Inc. | LLL | Class II | 2000-05-09 |
| K000752 | RHIGENE MESACUP2 TEST- RNP | Rhigene, Inc. | LKO | Class II | 2000-05-09 |
| K991801 | BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT | The Binding Site, Ltd. | MSV | Class II | 2000-05-05 |
| K991804 | BINDAZYME ANTI-B2 SCREEN EIA TEST KIT. | The Binding Site, Ltd. | MSV | Class II | 2000-05-05 |
| K991802 | BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT | The Binding Site, Ltd. | MSV | Class II | 2000-05-05 |
| K991803 | BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT. | The Binding Site, Ltd. | MSV | Class II | 2000-05-05 |
| K000701 | HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER | The Binding Site, Ltd. | CFN | Class II | 2000-04-27 |
| K000920 | REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | MID | Class II | 2000-04-26 |
| K001118 | MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | DiaSorin, Inc. | DFC | Class II | 2000-04-25 |
| K000661 | RANDOX PREALBUMIN | Randox Laboratories, Ltd. | JZJ | Class I | 2000-04-13 |
| K994221 | BAYER PSA ASSAY | Bayer Corp. | LTJ | Class II | 2000-04-13 |
| K000934 | MDI SCL-70 TEST | Micro Detect, Inc. | LJM | Class II | 2000-04-07 |
| K000534 | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II | Roche Diagnostics Corp. | DHR | Class II | 2000-04-05 |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | Helix Diagnostics, Inc. | LLL | Class II | 2000-04-05 |
| K000662 | RANDOX FERRITIN | Randox Laboratories, Ltd. | DBF | Class II | 2000-04-03 |
| K000468 | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | DBI | Class II | 2000-03-27 |
| K000469 | RANDOX COMPLEMENT C3 | Randox Laboratories, Ltd. | CZW | Class II | 2000-03-27 |
| K000286 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TG | Brahms Diagnostica, LLC | JZO | Class II | 2000-03-17 |
| K000312 | VARELISA SM ANTIBODIES | Pharmacia & Upjohn Co. | LKP | Class II | 2000-03-17 |
| K000287 | BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO | Brahms Diagnostica, LLC | JZO | Class II | 2000-03-17 |
| K000566 | MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | LTJ | Class II | 2000-03-09 |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Cogent Diagnotics , Ltd. | DHR | Class II | 2000-03-03 |
| K994293 | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | DBI | Class II | 2000-03-01 |
| K994296 | DIMENSION C3 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | CZW | Class II | 2000-03-01 |
| K000477 | MDI DS-DNA TEST | Micro Detect, Inc. | LRM | Class II | 2000-03-01 |
| K000132 | ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8 | Pharmacia & Upjohn Co. | DHB | Class II | 2000-02-18 |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | LRM | Class II | 2000-02-18 |
| K994379 | EU-TTG IGA ELISA | Scimedx Corp. | MVM | Class II | 2000-02-18 |
| K000196 | ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 | Beckman Coulter, Inc. | DDR | Class II | 2000-02-18 |
| K000363 | MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | DDC | Class II | 2000-02-18 |
| K000362 | MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | JZO | Class II | 2000-02-18 |
| K994294 | DIMENSION TRNF FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | DDG | Class II | 2000-02-04 |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Cogent Diagnotics , Ltd. | DHR | Class II | 2000-02-03 |
| K993549 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR | Beckman Coulter, Inc. | CFN | Class II | 2000-02-01 |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | Cogent Diagnotics , Ltd. | MID | Class II | 2000-02-01 |
| K993547 | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB | Beckman Coulter, Inc. | CFN | Class II | 2000-02-01 |
| K993928 | WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | DEW | Class II | 2000-01-18 |
| K994071 | RHIGENE ANA ELISA TEST SYSTEM | Rhigene, Inc. | LJM | Class II | 2000-01-18 |
| K993927 | WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD | Wako Chemicals USA, Inc. | CZP | Class II | 2000-01-14 |
| K993924 | WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD | Wako Chemicals USA, Inc. | CFN | Class II | 2000-01-14 |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | Trinity Biotech USA | LLL | Class II | 2000-01-12 |
| K993971 | MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM | Micro Detect, Inc. | LLL | Class II | 2000-01-11 |
| K993843 | MDI RF TEST | Micro Detect, Inc. | DHR | Class II | 2000-01-11 |
| K994029 | MDI SM TEST | Micro Detect, Inc. | LLL | Class II | 2000-01-11 |
| K993635 | MDI SM/RNP TEST | Micro Detect, Inc. | LJM | Class II | 2000-01-10 |
| K993636 | MDI SS-A TEST | Micro Detect, Inc. | LJM | Class II | 2000-01-10 |
| K993585 | VARELISA TPO ANTIBODIES, MODEL 12348/12396 | Pharmacia & Upjohn Co. | JZO | Class II | 2000-01-05 |
| K993727 | BINDAZYME ANTI-DSDNA EIA KIT | The Binding Site, Ltd. | LRM | Class II | 1999-12-21 |
| K993612 | BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA | The Binding Site, Ltd. | MVM | Class II | 1999-12-21 |
| K981784 | IGM MININEPH ANTISERUM | The Binding Site, Ltd. | CFN | Class II | 1999-12-21 |
| K994110 | LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET | Diasorin/American Standard Companies | DFC | Class II | 1999-12-21 |
| K981785 | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | DBI | Class II | 1999-12-20 |
| K982100 | IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS | The Binding Site, Ltd. | CFN | Class II | 1999-12-20 |
| K981783 | C3 MININEPH ANTISERUM | The Binding Site, Ltd. | CZW | Class II | 1999-12-20 |
| K993711 | ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) | Bayer Corp. | JZG | Class II | 1999-12-16 |
| K992188 | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 | Nichols Institute Diagnostics | JNM | Class II | 1999-12-06 |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Cogent Diagnotics , Ltd. | DHR | Class II | 1999-12-06 |
| K993388 | ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F | Pharmacia & Upjohn Co. | DHB | Class II | 1999-12-01 |
| K993323 | K-ASSAY IGM | Kamiya Biomedical Co. | CFF | Class II | 1999-11-30 |
| K993537 | K-ASSAY TRANSFERRIN | Kamiya Biomedical Co. | DDG | Class II | 1999-11-30 |
| K993481 | K-ASSAY C4 | Kamiya Biomedical Co. | DBI | Class II | 1999-11-29 |
| K993589 | VARELISA RNP ANTIBODIES | Pharmacia & Upjohn Co. | LKO | Class II | 1999-11-26 |
| K992665 | MACRA LP(A) ENZYME IMMUNOASSAY KIT | Trinity Biotech USA | DFC | Class II | 1999-11-26 |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | Cogent Diagnotics , Ltd. | MID | Class II | 1999-11-24 |
| K993441 | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | LKL | Class I | 1999-11-24 |
| K993444 | K-ASSAY ALPHA-1 AT | Kamiya Biomedical Co. | DEM | Class II | 1999-11-24 |
| K981786 | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | CFQ | Class II | 1999-11-24 |
| K993437 | K-ASSAY C3 | Kamiya Biomedical Co. | CZW | Class II | 1999-11-24 |
| K993480 | K-ASSAY HAPTOGLOBIN | Kamiya Biomedical Co. | DAD | Class II | 1999-11-24 |
| K993213 | K-ASSAY IGA | Kamiya Biomedical Co. | CFF | Class II | 1999-11-23 |
3,548 clearances in the Immunology panel. Data: openFDA.