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510(k) K801959

FTA-ABS TEST by Immuno-Diagnostic Products, Inc. — Product Code JWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Treponema Pallidum For Fta-Abs Test
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Immuno-Diagnostic Products, Inc.

  • K854207 — EBV(EPSTEIN-BARR VIRUS) TEST KIT (April 24, 1986)
  • K811021 — HERPES (November 5, 1981)
  • K811562 — TOXOPLASMOSIS TEST KIT (July 16, 1981)
  • K811022 — ANA TEST KIT (April 23, 1981)
  • K801963 — CMV TEST KIT (October 23, 1980)
  • K801961 — RF-II TEST KIT (October 10, 1980)
  • K801960 — ANTI-DS/N-DNA TEST KIT (October 10, 1980)

Other clearances for product code JWL

  • K831296 — POLYCHACO FIA-ABS TEST FOR SYPHILIS (July 26, 1983)
  • K802276 — FTA-ABS BIOPAK (October 23, 1980)
  • K801928 — LAB-TEK FTA-ABS KIT (August 20, 1980)