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510(k) K831296

POLYCHACO FIA-ABS TEST FOR SYPHILIS by Parasitic Disease Consultants — Product Code JWL

K831296 is an FDA 510(k) premarket notification submitted by Parasitic Disease Consultants for the device "POLYCHACO FIA-ABS TEST FOR SYPHILIS". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code JWL (Antigen, Treponema Pallidum For Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Parasitic Disease Consultants has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 20, 1983
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 Parasitic Disease Consultants

  • K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION (August 12, 1983)
  • K830869 — POLYCHACO INDIRECT IMMUNOFLUORESCENCE (August 11, 1983)

Other clearances for product code JWL

  • K801959 — FTA-ABS TEST (October 23, 1980)
  • K802276 — FTA-ABS BIOPAK (October 23, 1980)
  • K801928 — LAB-TEK FTA-ABS KIT (August 20, 1980)

FDA data resources