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510(k) K801959

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

K801959 is an FDA 510(k) premarket notification submitted by Immuno-Diagnostic Products, Inc. for the device "FTA-ABS TEST". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JWL (Antigen, Treponema Pallidum For Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Immuno-Diagnostic Products, Inc. has at least 7 other 510(k) clearances on record.

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)

FDA data resources