Home / 510(k) Clearances / K231616

510(k) K231616

ZEUS IFA(TM) nDNA Test System, ZEUS dIFine by Zeus Scientific — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2023
Date Received
June 2, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Zeus Scientific

  • K250666 — Alegria Flash CTD Screen (October 22, 2025)
  • K250408 — Alegria Flash ENA Screen (September 19, 2025)
  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia Vl (July 13, 2023)
  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K191398 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K190907 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K191240 — ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdo (July 29, 2019)
  • K113397 — ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM (July 26, 2012)
  • K102425 — ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (December 12, 2011)

Other clearances for product code KTL

  • K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Te (May 26, 2023)
  • K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit (December 11, 2020)
  • K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (April 20, 2018)
  • K011068 — RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (April 11, 2002)
  • K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G (November 29, 2001)
  • K990916 — INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY (April 21, 1999)
  • K930987 — CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) (August 10, 1993)
  • K905386 — DISTAT ANTI-DSDNA KIT (December 13, 1990)
  • K864275 — ANTI-NDNA ANTIBODY TEST KIT (December 15, 1986)