Endotoxin Activity Assay (Eaa) Device

No FDA recalls found in the data synced 11 Oct 2026.

De Novo Number

DEN030002 ↗

FDA Product Code

NGS

Device Class

Class II

Regulation

21 CFR Part 866.3210

Advisory Committee

Microbiology

FDA Decision

DENG De Novo granted

• Spectral Cardiac Status Ck-Mb/Myoglobin/Troponin I 3-In-1 Test

  Class II

  FDA 510(k) K030057 Active Cleared 19 Mar 2003

• Cardioquant Troponin I Test

  Class II

  FDA 510(k) K992127 Active Cleared 4 Oct 1999

• Spectral West Nile Virus Igm Status Test

  Class II

  FDA 510(k) K052519 Active Cleared 30 Nov 2006

• Spectral's 2 in 1 (Tni-Myo)

  Class II

  FDA 510(k) K020950 Active Cleared 24 May 2002

• Spectral's Cardiac Status Ck-Mb Rapid Test

  Class II

  FDA 510(k) K022409 Active Cleared 30 Sep 2002

• Cardiac Status Controls

  Class I

  FDA 510(k) K972408 Active Cleared 25 Jul 1997

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