Home / 510(k) Clearances / K810985

510(k) K810985

ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT by Immuno-Products Industries — Product Code DHN

K810985 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT". The FDA issued a decision of Substantially Equivalent on May 1, 1981. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), 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
May 1, 1981
Date Received
April 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
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)
  • K830652 — ANTI N DNA-HCP (March 24, 1983)
  • K821576 — ANTINUCLEAR ANTIBODY SCREEN FLOURESC (June 10, 1982)
  • 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 DHN

  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (July 28, 2016)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)

FDA data resources