KTL — Anti-Dna Indirect Immunofluorescent Solid Phase Class II
FDA product code KTL covers "Anti-Dna Indirect Immunofluorescent Solid Phase", a Class II medical device regulated under 21 CFR 866.5100. Submissions are reviewed by the Immunology panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KTL
- 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 |
|---|---|---|---|
| K231616 | zeus scientific | ZEUS IFA(TM) nDNA Test System, ZEUS dIFine | August 31, 2023 |
| K203599 | immuno concepts, n.a. | Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Te | May 26, 2023 |
| K192916 | inova diagnostics | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | December 11, 2020 |
| K172244 | euroimmun us | EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern | April 20, 2018 |
| K172252 | euroimmun us | EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | April 20, 2018 |
| K011068 | rhigene | RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L | April 11, 2002 |
| K013432 | immuno concepts | IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G | November 29, 2001 |
| K990916 | stellar bio systems | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY | April 21, 1999 |
| K930987 | binding site | CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) | August 10, 1993 |
| K905386 | shield diagnostics | DISTAT ANTI-DSDNA KIT | December 13, 1990 |
| K864275 | cappel diagnostics | ANTI-NDNA ANTIBODY TEST KIT | December 15, 1986 |
| K861978 | technia diagnostics | AUTOFLUOR V | June 10, 1986 |
| K842707 | apple diagnostic products | ADP NDNA IFA TEST | August 21, 1984 |
| K834349 | sigma chemical | ANTI-NATIVE DNA ANTIBODY | April 19, 1984 |
| K834140 | intl. diagnostic technology | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS | January 20, 1984 |
| K833984 | intl. diagnostic technology | ANTINUCLEAR ANTIBODY IMMUNOLOGICAL | January 4, 1984 |
| K832031 | breit laboratories | ANTI-N DNA ANTIBODY TEST KIT | August 11, 1983 |
| K830652 | immuno-products industries | ANTI N DNA-HCP | March 24, 1983 |
| K791354 | amersham | CODE QAS 103 ANTI-DNA CONTROLS | September 17, 1979 |