Home / 510(k) Clearances / K972884

510(k) K972884

ACCURUN 146 CMV IGM POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code LKQ

K972884 is an FDA 510(k) premarket notification submitted by Boston Biomedica, Inc. for the device "ACCURUN 146 CMV IGM POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on August 22, 1997. The device falls under product code LKQ (Antibody Igm,If, Cytomegalovirus Virus), a Class II device regulated under 21 CFR 866.3175. Boston Biomedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1997
Date Received
August 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibody Igm,If, Cytomegalovirus Virus
Device Class
Class II
Regulation Number
866.3175
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)
  • K974809 — ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL (February 5, 1998)
  • K974810 — ACCURUN(TM) 132 BORRELIA BURDORFERI IGM 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)
  • K971657 — ACCURUN 121 HAV IGM POSITIVE CONTROL (August 12, 1997)
  • K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL (August 12, 1997)
  • K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL (August 7, 1997)

Other clearances for product code LKQ

  • K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUS (May 13, 2010)
  • K933549 — VIDAS CMV IGM ASSAY (August 2, 1994)
  • K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA (April 8, 1993)
  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K913080 — OPUS(R) ANTI CMV-M (October 28, 1991)
  • K900743 — CMV-IGM IFA TEST SYSTEM (April 26, 1990)
  • K893465 — CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) (July 25, 1989)
  • K893466 — CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) (July 14, 1989)
  • K872881 — ABBOTT CMV-M EIA KIT (May 13, 1988)
  • K872942 — IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 (January 11, 1988)

FDA data resources