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510(k) K192916

NOVA Lite DAPI dsDNA Crithidia luciliae Kit by Inova Diagnostics, Inc. — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2020
Date Received
October 15, 2019
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

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Other clearances for product code KTL

  • K231616 — ZEUS IFA(TM) nDNA Test System, ZEUS dIFine (August 31, 2023)
  • K203599 — Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Te (May 26, 2023)
  • 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)