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510(k) K834349

ANTI-NATIVE DNA ANTIBODY by Sigma Chemical Co. — Product Code KTL

K834349 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "ANTI-NATIVE DNA ANTIBODY". The FDA issued a decision of Substantially Equivalent on April 19, 1984. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1984
Date Received
December 13, 1983
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

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)
  • 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)

FDA data resources