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FDA 510(k) Applications for Medical Device Product Code "DFZ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K955906 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNHEIM IGG ASSAY | 02/09/1996 |
K803272 | ICL SCIENTIFIC | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG | 01/26/1981 |
K812821 | IMMULOK, INC. | H-103 IGG, H-104 IGA, H-105 IGM | 10/26/1981 |
K790720 | KENT LABORATORIES, INC. | ANTISERA TO RABBIT IMMUNOGLOBULIN | 08/16/1979 |
K790709 | KENT LABORATORIES, INC. | ANTISERUM TO RABBIT IMMUNOGLOBULIN | 08/16/1979 |
K020823 | SANQUIN BLOOD SUPPLY FOUNDATION | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT | 05/14/2002 |
K092283 | SIEMENS HEALTHCARE DIAGNOSTICS | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG | 10/21/2009 |
K021081 | THE BINDING SITE, LTD. | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER | 06/17/2002 |
K940422 | THE BINDING SITE, LTD. | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER | 05/27/1994 |