Accurun 140 Rubella Igg Positive Control

510(k) Number

K972986 ↗

FDA Product Code

MJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Accurun 121 Hav Igm Positive Control

  Class I

  FDA 510(k) K971657 Active Cleared 12 Aug 1997

• Accurun 135 Toxoplasma Igg Positive Control

  Class II

  FDA 510(k) K974261 Active Cleared 11 Dec 1997

• Bbi-Biotech Research Laboratories B. Burgdorferi Igm Western Blot Kit

  Class II

  FDA 510(k) K980351 Active Cleared 5 Mar 1999

• Accurun(Tm) 150 Hsv Igg Positive Control

  Class I

  FDA 510(k) K974811 Active Cleared 10 Feb 1998

• Accurun 117 Hbeag Positive Control

  Class I

  FDA 510(k) K972048 Active Cleared 12 Aug 1997

• Boston Biomedica, Inc. Borrelia Burgdorferi Igm and Igg

  Class II

  FDA 510(k) K032713 Active Cleared 24 Nov 2003

See all devices from Boston Biomedica, Inc. →