DAS
8 FDA 510(k) clearances · Product code
73 daysmedian time to decision
132 days90th percentile
8clearances measured
FDA profile
- Official device name
- Igg (Fc Fragment Specific), Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5530
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023) | Inova Diagnostics, Inc. | 1998-09-04 |
| HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT (K944876) | Research Diagnostics, Inc. | 1994-12-15 |
| HUMAN IGG SUBCLASSES ELISA COMBI KIT (K943098) | Research Diagnostics, Inc. | 1994-09-07 |
| HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) (K943205) | Research Diagnostics, Inc. | 1994-09-07 |
| HUMAN (IGG) SUBCLASS (EIA) KIT (K895600) | The Binding Site, Ltd. | 1989-11-08 |
| ANTISERUM TO HUMAN IG G FC FRAGMENTS (K790708) | Kent Laboratories, Inc. | 1979-08-22 |
| ANTISERUM TO HUMAN FC (K790715) | Kent Laboratories, Inc. | 1979-08-16 |
| AMINOGLYCOSIDE CONTROLS (K761156) | Supelco, Inc. | 1976-12-09 |
Track DAS automatically
Every clearance here is in the API, with alerts when new ones post.