Igg (Fc Fragment Specific), Antigen, Antiserum, Control
This is an immunological reagent kit for detecting the Fc fragment of immunoglobulin G (IgG), the crystallizable region of the antibody that mediates effector functions such as complement activation and binding to Fc receptors. The kit includes antigen, antiserum, and control components for immunochemical analysis. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The product code is DAS, regulated under 21 CFR 866.5530, within the Immunology specialty.
Basic Information
- Product Code
- DAS
- Device Class
- FDA class 1
- Regulation Number
- 866.5530
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K982023 | PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT | Sep 04, 1998 | Substantially Equivalent | INOVA DIAGNOSTICS, INC. |
| K944876 | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT | Dec 15, 1994 | Substantially Equivalent | RESEARCH DIAGNOSTICS, INC. |
| K943205 | HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION) | Sep 07, 1994 | Substantially Equivalent | RESEARCH DIAGNOSTICS, INC. |
| K943098 | HUMAN IGG SUBCLASSES ELISA COMBI KIT | Sep 07, 1994 | Substantially Equivalent | RESEARCH DIAGNOSTICS, INC. |
| K895600 | HUMAN (IGG) SUBCLASS (EIA) KIT | Nov 08, 1989 | Substantially Equivalent | THE BINDING SITE, LTD. |
| K790708 | ANTISERUM TO HUMAN IG G FC FRAGMENTS | Aug 22, 1979 | Substantially Equivalent | KENT LABORATORIES, INC. |
| K790715 | ANTISERUM TO HUMAN FC | Aug 16, 1979 | Substantially Equivalent | KENT LABORATORIES, INC. |
| K761156 | AMINOGLYCOSIDE CONTROLS | Dec 09, 1976 | Substantially Equivalent | SUPELCO, INC. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.