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510(k) K972986

ACCURUN 140 RUBELLA IGG POSITIVE CONTROL by Boston Biomedica, Inc. — Product Code MJX

K972986 is an FDA 510(k) premarket notification submitted by Boston Biomedica, Inc. for the device "ACCURUN 140 RUBELLA IGG POSITIVE CONTROL". The FDA issued a decision of Substantially Equivalent on October 8, 1997. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Boston Biomedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 1997
Date Received
August 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
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)
  • K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL (August 22, 1997)
  • K972048 — ACCURUN 117 HBEAG POSITIVE CONTROL (August 12, 1997)
  • K971657 — ACCURUN 121 HAV IGM POSITIVE CONTROL (August 12, 1997)
  • K971406 — ACCURUN 120 HAV IGG POSITIVE CONTROL (August 7, 1997)

Other clearances for product code MJX

  • K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY (July 22, 2010)
  • K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (January 17, 2003)
  • K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G (December 24, 1997)
  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)

FDA data resources