CFN — Method, Nephelometric, Immunoglobulins (G, A, M) Class II
FDA product code CFN covers "Method, Nephelometric, Immunoglobulins (G, A, M)", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CFN
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233663 | siemens healthcare diagnostics products | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | December 13, 2023 |
| K221114 | beckman coulter laboratory systems (suzhou) co | Immunoglobulin G (IgG) | August 2, 2023 |
| K192116 | binding site group | Human IgA liquid reagent kit for Use on SPAPlus | September 4, 2019 |
| K191985 | binding site group | Optilite IgA Kit | August 19, 2019 |
| K191635 | binding site group | Optilite IgM Kit | July 15, 2019 |
| K191465 | binding site group | Human IgM Kit for use on SPAPlus | June 27, 2019 |
| K190686 | binding site group | Optilite IgM CSF Kit | May 28, 2019 |
| K183151 | binding site group | Optilite IgA CSF Kit | January 23, 2019 |
| K162208 | beckman coulter | DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent | January 9, 2017 |
| K150526 | binding site group | Optilite IgG4 Kit | May 30, 2015 |
| K142735 | binding site group | The Optilite IgG3 kit | December 21, 2014 |
| K130122 | beckman coulter | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, | January 7, 2014 |
| K120901 | binding site group | HUMAN IGA CSF KIT FOR USE ON SPAPLUS | May 30, 2013 |
| K120750 | binding site group | HUMAN IGM CSF KIT | May 17, 2013 |
| K120749 | binding site group | HUMAN IGG CSF KIT | May 17, 2013 |
| K113823 | binding site group | HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT | March 27, 2013 |
| K103824 | binding site | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS | February 27, 2012 |
| K100588 | binding site group | HUMAN IGA2 KIT FOR USE ON THE SPAPLUS | August 16, 2010 |
| K082823 | binding site group | HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS | March 1, 2010 |
| K090920 | binding site | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD | December 30, 2009 |