Panels › Immunology › Product code DAS · Class 1
Igg (Fc Fragment Specific), Antigen, Antiserum, Control
Regulation 866.5530
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DAS
| Company | 510(k)s | Recalls |
|---|---|---|
| Research Diagnostics, Inc. | 3 | 0 |
| Kent Laboratories, Inc. | 2 | 0 |
| The Binding Site, Ltd. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Supelco, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 1998 | K982023 | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT Inova Diagnostics, Inc. | DAS |
| Dec 15, 1994 | K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT Research Diagnostics, Inc. | DAS |
| Sep 7, 1994 | K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) Research Diagnostics, Inc. | DAS |
| Sep 7, 1994 | K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT Research Diagnostics, Inc. | DAS |
| Nov 8, 1989 | K895600 | HUMAN (IGG) SUBCLASS (EIA) KIT The Binding Site, Ltd. | DAS |
| Aug 22, 1979 | K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS Kent Laboratories, Inc. | DAS |
| Aug 16, 1979 | K790715 | ANTISERUM TO HUMAN FC Kent Laboratories, Inc. | DAS |
| Dec 9, 1976 | K761156 | AMINOGLYCOSIDE CONTROLS Supelco, Inc. | DAS |
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