ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS— 510(k) K834140
Substantially EquivalentIntl. Diagnostic Technology
FDA 510(k) clearance K834140 for ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS, Substantially Equivalent on 1984-01-20. Applicant: Intl. Diagnostic Technology. Device class: 2.
Clearance details
- Applicant
- Intl. Diagnostic Technology
- Product code
- Code KTL
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KTL
view all- K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
- K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
- K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit
- K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
- K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
More clearances from Intl. Diagnostic Technology
view allData sourced from openFDA. This site is unofficial and independent of the FDA.