Home / 510(k) Clearances / K853122

510(k) K853122

IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED by Immuno-Products Industries — Product Code GMS

K853122 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED". The FDA issued a decision of Substantially Equivalent on September 19, 1985. The device falls under product code GMS (Anti-Human Globulin, Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Immuno-Products Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1985
Date Received
July 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Human Globulin, Fta-Abs Test
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Immuno-Products Industries

  • 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)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)
  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)

Other clearances for product code GMS

  • K843613 — FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (October 31, 1984)
  • K781403 — FTA-ABS TEST SYSTEM (August 21, 1978)

FDA data resources