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510(k) K831296

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

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)