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510(k) K830652

ANTI N DNA-HCP by Immuno-Products Industries — Product Code KTL

K830652 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "ANTI N DNA-HCP". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Immuno-Products Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
March 7, 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 Immuno-Products Industries

  • K853122 — IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (September 19, 1985)
  • K852230 — ANA/LITE-RL TEST SYSTEM (July 10, 1985)
  • K852231 — ANA/LITE-HEP-2 TEST SYSTEM (July 10, 1985)
  • K843613 — FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (October 31, 1984)
  • K831054 — ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB (April 27, 1983)
  • K821576 — ANTINUCLEAR ANTIBODY SCREEN FLOURESC (June 10, 1982)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)

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)
  • K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (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