Adenovirus Antigen Detection Elisa Test System

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K972406 ↗

FDA Product Code

GOD

Device Class

Class I

Regulation

21 CFR Part 866.3020

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Cardiolipin Igm Eia Test System

  Class II

  FDA 510(k) K952521 Active Cleared 9 Feb 1996

• Microsomal Eia Test Kit

  Class II

  FDA 510(k) K941361 Active Cleared 11 May 1994

• Cardiolipin Igg, M, a Eia Test Kit

  Class II

  FDA 510(k) K952520 Active Cleared 15 Sep 1995

• Mpo Elisa Test System

  Class II

  FDA 510(k) K961765 Active Cleared 19 Aug 1996

• Cardiolipin Igg Eia Test Kit

  Class II

  FDA 510(k) K952523 Active Cleared 9 Feb 1996

• Cardiolipin Iga Eia Test System

  Class II

  FDA 510(k) K952522 Active Cleared 9 Feb 1996

See all devices from Immunoprobe, Inc. →