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510(k) K861460

SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 by Widran Urological Group, Ltd. — Product Code LJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, If, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Widran Urological Group, Ltd.

  • K822743 — SOLID STATE CONTINUOUS FLOW CONTROL (September 24, 1982)

Other clearances for product code LJK

  • K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (December 11, 1997)
  • K911771 — ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (July 1, 1991)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)