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510(k) K972048

ACCURUN 117 HBEAG POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1997
Date Received
June 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
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)
  • K974261 — ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL (December 11, 1997)
  • 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)
  • K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL (August 7, 1997)

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  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)