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510(k) K911771

ARD(TM) ANTIMICROBIAL REMOVAL DEVICE by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1991
Date Received
April 19, 1991
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

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Other clearances for product code LJK

  • K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (December 11, 1997)
  • K861122 — THE GOLDEN QUAD TEST (TOXO) (February 2, 1987)
  • K861460 — SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 (May 2, 1986)
  • K832069 — TOXO IPA KIT IAN INDIRECT FLUORESCENT (September 26, 1983)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)