Accurun(Tm) 132 Borrelia Burdorferi Igm Positive Control

510(k) Number

K974810 ↗

FDA Product Code

LSR

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Accurun 140 Rubella Igg Positive Control

  Class I

  FDA 510(k) K972986 Active Cleared 8 Oct 1997

• 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

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