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510(k) K974261

ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code LJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1997
Date Received
November 13, 1997
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 Boston Biomedica, Inc.

  • K032713 — BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG (November 24, 2003)
  • K980351 — BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT (March 5, 1999)
  • K974811 — ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL (February 10, 1998)
  • K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL (February 5, 1998)
  • K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (February 5, 1998)
  • K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K971657 — ACCURUN 121 HAV IGM POSITIVE CONTROL (August 12, 1997)
  • K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL (August 12, 1997)
  • K972307 — ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL (August 7, 1997)

Other clearances for product code LJK

  • K911771 — ARD(TM) ANTIMICROBIAL REMOVAL DEVICE (July 1, 1991)
  • 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)