Home / 510(k) Clearances / K843613

510(k) K843613

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB by Immuno-Products Industries — Product Code GMS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 10, 1984
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

  • K853122 — IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (September 19, 1985)
  • K852231 — ANA/LITE-HEP-2 TEST SYSTEM (July 10, 1985)
  • K852230 — ANA/LITE-RL TEST SYSTEM (July 10, 1985)
  • 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)
  • K810982 — ANTITHYROID ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810983 — ANTISMOOTH MUSCLE ANTIBODY TEST SYS (May 1, 1981)
  • K810985 — ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT (May 1, 1981)
  • K810984 — ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST (May 1, 1981)

Other clearances for product code GMS

  • K853122 — IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (September 19, 1985)
  • K781403 — FTA-ABS TEST SYSTEM (August 21, 1978)