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Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
43
Latest Decision
1983-10-31

Clearances · page 31 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K832265 FITC GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. DFT Class II 1983-10-31
K832260 GOAT ANTI-HUMAN KAPPA AFFINITY Gelco Diagnostics, Inc. DEO Class II 1983-10-31
K832262 FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS Gelco Diagnostics, Inc. CZN Class II 1983-10-31
K832263 FITC GOAT ANTI-HUMAN IGA A CHAIN Gelco Diagnostics, Inc. CZP Class II 1983-10-31
K832258 GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC Gelco Diagnostics, Inc. DEW Class II 1983-10-31
K832256 GOAT ANTI-HUMAN IMMUNOGLOBULINS- Gelco Diagnostics, Inc. DFH Class II 1983-10-31
K832270 GOAT ANTI-HUMAN LAMBA Gelco Diagnostics, Inc. DEH Class II 1983-10-31
K832264 FITC GOAT ANTI-HUMAN IGG Y CHAIN Gelco Diagnostics, Inc. DEW Class II 1983-10-28
K832261 GOAT ANTI-HUMAN LAMBA AFFINITY Gelco Diagnostics, Inc. DEH Class II 1983-10-28
K832259 GOAT ANTI-HUMAN IGM H CHAIN Gelco Diagnostics, Inc. DFT Class II 1983-10-28
K832257 GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC Gelco Diagnostics, Inc. CZN Class II 1983-10-28
K832360 ABBOTT IGE EIA Abbott Laboratories DGC Class II 1983-10-14
K831987 EPSILON IGE TEST KIT Beckman Instruments, Inc. DGO Class II 1983-10-14
K832821 FIAX IGG TEST Intl. Diagnostic Technology DFI Class I 1983-10-14
K832218 ALLERGEN CONTROL INHALENT Ventrex Laboratories, Inc. DGC Class II 1983-09-20
K832217 VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD Ventrex Laboratories, Inc. DHB Class II 1983-09-20
K832675 ANA MICROZYME TEST SYS #1610 Clinical Sciences, Inc. DAA Class II 1983-09-12
K832383 IDT ANA STIQ ASSAY Intl. Diagnostic Technology DHN Class II 1983-08-31
K832054 FIAX CRP TEST KIT Intl. Diagnostic Technology DCK Class II 1983-08-26
K831870 ALLERGENETICS FLUORO-FAST READER Axonics, Inc. JZT Class I 1983-08-12
K832031 ANTI-N DNA ANTIBODY TEST KIT Breit Laboratories, Inc. KTL Class II 1983-08-11
K831408 DNA FLOR Medastat Scientific Corp. DHN Class II 1983-07-28
K831811 REVOLUTION RADIAL IMMUNODIFFUSION PLATE Calbiochem-Behring Corp. JZQ Class I 1983-07-28
K831903 FLUORESCEIN CONJUGATED IMMUNOGLOBULIN Dako Corp. DES Class II 1983-07-19
K831906 RABBIT ANTISERUM TO HUMAN C4 Dako Corp. DBI Class II 1983-07-19
K831958 RADIAL IMMUNO-TEST FOR HUMAN C-REACTI Kent Laboratories, Inc. DCK Class II 1983-07-19
K831960 TEST FOR HUMAN ALPHA ONE ACID GLYCO- Kent Laboratories, Inc. LKL Class I 1983-07-19
K831904 RABBIT ANTISERUM TO HUMAN KAPPA LIGHT Dako Corp. DEO Class II 1983-07-19
K831959 RADIAL IMMUNO-TEST FOR HUMAN FACTOR B Kent Laboratories, Inc. JZH Class II 1983-07-19
K831907 RABBIT ANTISERUM TO HUMAN IGM Dako Corp. DFS Class II 1983-07-19
K831927 ANTINUCLEAR ANTIBODY TEST KIT Breit Laboratories, Inc. DAA Class II 1983-07-18
K831909 RABBIT ANTISERUM TO HUMAN IGA Dako Corp. CZN Class II 1983-07-18
K831957 DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB Kent Laboratories, Inc. DAD Class II 1983-07-18
K831941 LEAP RHEUMATOID FACTOR TEST KIT Cooper Diagnostics, Inc. DHR Class II 1983-07-18
K831905 RABBITT ANTISERUM TO HUMAN C3C Dako Corp. CZW Class II 1983-07-18
K831908 RABBIT ANTISERUM TO HUMAN IGG Dako Corp. DGK Class II 1983-07-18
K831292 ANTI-ENA TEST Meloy Laboratories, Inc. LKO Class II 1983-07-18
K831956 DETERM. SIZE 72 RADIAL-HUMAN IGD Kent Laboratories, Inc. CZJ Class II 1983-07-18
K831902 FLUORESCEIN CONJUGATED IMMUNOGLOBIN- Dako Corp. DDZ Class II 1983-07-18
K831774 LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- Diagnostic Reagent Tech. DGO Class II 1983-07-18
K831603 TITAN GE/IEPLATE Helena Laboratories JZR Class I 1983-07-07
K831597 SERO/TEX RED CELL RF TEST Texas Immunology, Inc. DHR Class II 1983-06-30
K831608 FIAX IGM TEST KIT Intl. Diagnostic Technology DFT Class II 1983-06-22
K831607 FIAX IGA TEST KIT Intl. Diagnostic Technology CZN Class II 1983-06-22
K831609 FIAX IGG TEST KIT Intl. Diagnostic Technology DGK Class II 1983-06-17
K831358 AUTOANTIBODY SCREEN TEST SYSTEM Zeus Scientific, Inc. DBM Class II 1983-06-15
K830911 RADIAL IMMUNODIFFUSION PLATES Biocell Laboratories, Inc. DDG Class II 1983-06-10
K831463 ANA-CHECK Diagnostic Technology, Inc. LKJ Class II 1983-06-08
K831442 PHADEBAS & PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1983-06-08
K831554 NEIN ALLERGEN DISC IN VAST VENTREX TEST Ventrex Laboratories, Inc. DHB Class II 1983-06-08
K831467 RA-CHECK Diagnostic Technology, Inc. DHR Class II 1983-06-08
K831465 CRP-CHECK Diagnostic Technology, Inc. DCN Class II 1983-06-08
K831485 VENTRE/ZYME IGE KIT Ventrex Laboratories, Inc. DGC Class II 1983-06-02
K831326 ALLERCOAT ALLERGEN DISCS Kallestad Laboratories, Inc. DGC Class II 1983-06-02
K831377 IGE RADIOIMMUNOASSAY KIT American Diagnostic Corp. DGC Class II 1983-06-02
K830005 IP SPECIFIC G Diagnostic Reagent Tech. DAA Class II 1983-06-02
K831364 TESTCORP RA Myo-Tronics Research, Inc. DCN Class II 1983-05-27
K831362 TESTCORP CRP Catheter Technology Corp. DCN Class II 1983-05-27
K831208 IGE-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. DGC Class II 1983-05-09
K830580 DIAGNON FERRITIN 125 I RIA KIT Iagnon Corp. DBF Class II 1983-05-05
K821135 PREALBUMIN ENZYME IMMUNOASSAY Abbott Laboratories JZJ Class I 1983-05-05
K831100 MEDICA IIF-MULTIPLE ANTIBODY TEST KIT Medical Diagnostics, Ca. DBM Class II 1983-05-04
K831045 PHADEBAS & PHADEZYM RAST MIXED ALLERG Pharmacia, Inc. DHB Class II 1983-04-27
K831036 ENA TEST KIT SM & RNP AUTO ANTIBODY Calbiochem-Behring Corp. LLL Class II 1983-04-27
K831101 TIA-IGG REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems DEW Class II 1983-04-27
K830817 NEW ALLERGEN DISCS FOR USE IN VAST VENT Ventrex Laboratories, Inc. DGC Class II 1983-04-27
K831102 TIA-IGA REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems CZP Class II 1983-04-27
K831091 NEW ALLERGEN DISC -VAST VENTEX ALLERGY Ventrex Laboratories, Inc. DHB Class II 1983-04-27
K831103 TIA-IGM REAGENT & CALIBRATOR SETS Worthington Diagnostic Systems DFT Class II 1983-04-27
K831054 ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB Immuno-Products Industries DHN Class II 1983-04-27
K830832 RHEUMATOID FACTOR-RAPID CARD TEST #65114 Emd Chemicals, Inc. DHR Class II 1983-04-18
K830653 POLYSTYRENE MICROTITER PLATE IMMUNOSORB Diagnostic Reagent Tech. DGO Class II 1983-04-08
K830669 FIAX COMPLEMENT C4 TEST KIT Intl. Diagnostic Technology DBI Class II 1983-04-08
K830668 FIAX COMPLEMENT C3 TEST KIT Intl. Diagnostic Technology CZW Class II 1983-04-05
K830495 POLYSTYRENE MICROTITER PLATE IMMUNOSOR Diagnostic Reagent Tech. DGO Class II 1983-04-05
K830606 QUIK-SEP IGM ISOLATION SYSTEM Isolab, Inc. DFT Class II 1983-03-24
K830611 RA SCREENING TEST Tago, Inc. DHR Class II 1983-03-24
K830594 TITAN IMMUNO-FIX Helena Laboratories DEW Class II 1983-03-24
K823592 PHADEBAS & PHADEZYM RAST TEST ALLERG Pharmacia, Inc. DHB Class II 1983-03-24
K830652 ANTI N DNA-HCP Immuno-Products Industries KTL Class II 1983-03-24
K830591 CORNING FERRITIN 125I RADIOIMMUNOASSAY Corning Medical & Scientific DBF Class II 1983-03-24
K830531 MONO SCREENING TEST Tago, Inc. KTN Class II 1983-03-17
K830357 RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E Clinetics Corp. DGC Class II 1983-03-17
K823829 FERRITIN IMMUNORADIOMETRIC ASSAY KIT Bd Becton Dickinson Vacutainer Systems Preanalytic DFB Class II 1983-03-11
K830155 PHADEBAS & PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. DHB Class II 1983-03-10
K830214 AFT SYSTEM III Calbiochem-Behring Corp. DHN Class II 1983-03-09
K830229 ROENTGENOGRAPHY SET Mallinckrodt Critical Care DGD Class II 1983-03-09
K823884 PARAGON IMMUNOELECTROPHORESIS REAGENT Beckman Instruments, Inc. CFF Class II 1983-03-07
K830164 DENSITOMETRIC INHALENT PROFILE SLLER Mast Immunosystems DGC Class II 1983-03-01
K823871 TANDEM-E -FER IMMUNOENZYMETRIC KIT Hybritech, Inc. DBF Class II 1983-02-25
K823593 INHALANT PROFILE-ALLERGEN-SPECIFIC IGE Mast Immunosystems DHB Class II 1983-02-25
K830170 RIASSIST RAST DATA REDUCTION/QUALITY Ventrex Laboratories, Inc. DHB Class II 1983-02-07
K830096 PHADEBAS & PHADEZYME RAST ALLERGEN DISC Pharmacia, Inc. DHB Class II 1983-01-28
K823494 TOTAL IGE-FAST TEST Axonics, Inc. DGC Class II 1983-01-14
K823841 PHADEBAS RAST ALLERGEN DISCS Pharmacia, Inc. DGC Class II 1983-01-12
K823842 PHADEZYM RAST ALLERGEN DISCS Pharmacia, Inc. DGC Class II 1983-01-12
K823680 COAT-A-COUNT MORPHINE KIT & COMPONENTS Diagnostic Products Corp. DDE Class I 1983-01-05
K823765 ANTI SERA TO HUMAN OROSCOMUCOID Kent Laboratories, Inc. DEX Class I 1982-12-30
K823566 IMMUNOGLOBULIN CONTROL Syva Co. CZP Class II 1982-12-30
K823567 IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM Syva Co. CZP Class II 1982-12-30

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