Ideia(Tm) Chlamydia Blocking Reagents, Modification

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K940564 ↗

FDA Product Code

LJC

FDA applicant

Dako Diagnostics , Ltd.

Device Class

Class I

Regulation

21 CFR Part 866.3120

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Imagen

  Class I

  FDA 510(k) K943557 Active Cleared 9 Jan 1995

• Ideia(Tm) Rotavirus

  Class I

  FDA 510(k) K932384 Active Cleared 27 Dec 1993

• Imagearainfluenza Virus Group (Types 1, 2 and 3) Test and Imagen Parainfluenza Virus Test Types 1, 2 and 3

  Class I

  FDA 510(k) K981226 Active Cleared 28 Sep 1998

• Imagen Respiratory Screen

  Class I

  FDA 510(k) K962037 Active Cleared 26 Dec 1996

• Imagen Respiratory Screen

  Class I

  FDA 510(k) K973954 Active Cleared 22 Dec 1997