Igg (Gamma Chain Specific), Antigen, Antiserum, Control
FDA product code DFZ · Class II (moderate risk) · 21 CFR 866.5510 · Immunology
9510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K092283 | Dimension Vista Immunoglobulin Igg Subclasss 1FLEX Reagent Cartridge, Dimension Vista…DFZ · Traditional | Siemens Healthcare Diagnostics | 10/21/2009SE |
| K021081 | Human Igg Subclass Liquid Reagent Kits for Use on the Hitachi 911/7070 Turbidimetric…DFZ · Traditional | The Binding Site, Ltd. | 06/17/2002SE |
| K020823 | Peliclass Human Igg Subclass Nephelometric Immage KitDFZ · Traditional | Sanquin Blood Supply Foundation | 05/14/2002SE |
| K955906 | Boehringer Mannheim Igg AssayDFZ · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K940422 | Igg Subclass Single Dilution Diagnostic Kit for Use with the Beckman Array AnalyzerDFZ · Traditional | The Binding Site, Ltd. | 05/27/1994SE |
| K812821 | H-103 Igg, H-104 Iga, H-105 IgmDFZ · Traditional | Immulok, Inc. | 10/26/1981SE |
| K803272 | Automated Immunoprecipitin Method/IcgDFZ · Traditional | Icl Scientific | 01/26/1981SE |
| K790720 | Antisera to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |
| K790709 | Antiserum to Rabbit ImmunoglobulinDFZ · Traditional | Kent Laboratories, Inc. | 08/16/1979SE |