Imagen Influenza Virus a and B Testmi

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

510(k) Number

K872958 ↗

FDA Product Code

GNX

Device Class

Class I

Regulation

21 CFR Part 866.3330

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Sucrosep Human Growth Hormone (Hgh) Irma

  Class I

  FDA 510(k) K860228 Active Cleared 28 Feb 1986

• Modified Imagen(Tm) Chlamydia Test

  Class I

  FDA 510(k) K864539 Active Cleared 12 Mar 1987

• Sucrosep Human Prolactin (Hpr) Irma

  Class I

  FDA 510(k) K861271 Active Cleared 27 Jun 1986

• Sucrosep Thyroid Stimulating Hormone

  Class II

  FDA 510(k) K842593 Active Cleared 12 Sep 1984

• Modified Ideia Chlamydia Test

  Class I

  FDA 510(k) K861966 Active Cleared 19 Aug 1986

• Oveia (Tm) Dual Analyte

  Class I

  FDA 510(k) K872843 Active Cleared 2 Feb 1988

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