Cardiolipin Igg, M, a Eia Test System

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

510(k) Number

K951363 ↗

FDA Product Code

MID

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

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. →