DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Class II
FDA product code DHN covers "Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control", a Class II medical device regulated under 21 CFR 866.5100. 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
- DHN
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201956 | zeus scientific | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | April 29, 2022 |
| K172745 | immco diagnostics | ImmuGlo HEp-2 Elite IFA | June 5, 2018 |
| K153117 | aesku systems gmbh and co.kg | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | July 28, 2016 |
| K160265 | immuno concepts, n.a. | Image Navigator by Immuno Concepts | June 17, 2016 |
| K141827 | euroimmun us | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | April 17, 2015 |
| K150155 | inova diagnostics | NOVA Lite DAPI ANA Kit | April 8, 2015 |
| K131791 | euroimmun us | IFA 40: HEP-20-10 | February 26, 2014 |
| K120889 | aesku diagnostics | AESKUSLIDES ANA HEP-2 | October 15, 2012 |
| K070763 | euroimmun us | EUROIMMUN ANA IFA: HEP-20-10 | May 22, 2007 |
| K042680 | corgenix | RHIGENE HEP-ANA TEST SYSTEM | November 19, 2004 |
| K024220 | bio-rad | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | January 17, 2003 |
| K024222 | bio-rad | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | January 15, 2003 |
| K024230 | bio-rad | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLE | January 15, 2003 |
| K024217 | bio-rad | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | January 15, 2003 |
| K024221 | bio-rad | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | January 15, 2003 |
| K024229 | bio-rad | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | January 15, 2003 |
| K024227 | bio-rad | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | January 15, 2003 |
| K024224 | bio-rad | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | January 15, 2003 |
| K024225 | bio-rad | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | January 15, 2003 |
| K024231 | bio-rad | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | January 13, 2003 |