Panels › Immunology › Product code DFZ · Class 2
Igg (Gamma Chain Specific), Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DFZ
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site, Ltd. | 2 | 0 |
| Kent Laboratories, Inc. | 2 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Icl Scientific | 1 | 0 |
| Immulok, Inc. | 1 | 0 |
| Sanquin Blood Supply Foundation | 1 | 0 |
| Siemens Healthcare Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2009 | K092283 | DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG Siemens Healthcare Diagnostics | DFZ |
| Jun 17, 2002 | K021081 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER The Binding Site, Ltd. | DFZ |
| May 14, 2002 | K020823 | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT Sanquin Blood Supply Foundation | DFZ |
| Feb 9, 1996 | K955906 | BOEHRINGER MANNHEIM IGG ASSAY Boehringer Mannheim Corp. | DFZ |
| May 27, 1994 | K940422 | IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER The Binding Site, Ltd. | DFZ |
| Oct 26, 1981 | K812821 | H-103 IGG, H-104 IGA, H-105 IGM Immulok, Inc. | DFZ |
| Jan 26, 1981 | K803272 | AUTOMATED IMMUNOPRECIPITIN METHOD/ICG Icl Scientific | DFZ |
| Aug 16, 1979 | K790720 | ANTISERA TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. | DFZ |
| Aug 16, 1979 | K790709 | ANTISERUM TO RABBIT IMMUNOGLOBULIN Kent Laboratories, Inc. | DFZ |
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