Home / 510(k) Clearances / K011068

510(k) K011068

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L by Rhigene, Inc. — Product Code KTL

K011068 is an FDA 510(k) premarket notification submitted by Rhigene, Inc. for the device "RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L". The FDA issued a decision of Substantially Equivalent on April 11, 2002. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Rhigene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2002
Date Received
April 9, 2001
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 Rhigene, Inc.

  • K040711 — MESACUP TEST PR-3 (April 2, 2004)
  • K040586 — MESACUP TEST MPO, MODEL 11053 (March 22, 2004)
  • K040200 — MESACUP-2 TEST CENP-B (March 4, 2004)
  • K033528 — MESACUP-2 TEST JO-1, MODEL 10756 (December 22, 2003)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741 (August 14, 2002)
  • K022018 — RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560 (July 5, 2002)
  • K000336 — RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E (June 9, 2000)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000751 — RHIGENE MESACUP2 TEST- SSB (May 9, 2000)

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)
  • 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)
  • 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)

FDA data resources