Complete Human Tubal Fluid (Htf) with Serum Substitute Supplement, Model 9922

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K003278 ↗

FDA Product Code

MQL

Device Class

Class II

Regulation

21 CFR Part 884.6180

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Human Serum Albumin (Hsa)

  Class II

  FDA 510(k) K983584 Active Cleared 8 Feb 1999

• Continuous Single Culture Complete

  Class II

  FDA 510(k) K121572 Active Cleared 19 Jul 2012

• Oil for Embryo Culture Open recall

  Class II

  FDA 510(k) K011938 Active Cleared 18 Jul 2001

• Htf Medium, Modified Htf Medium- Hepes, Htf Powder (Without Antibiotics), Modified Htg Powder- Hepes (Without Antiboditi

  Class II

  FDA 510(k) K983586 Active Cleared 18 Feb 1999

• Phenol Red Stock Solution

  Class II

  FDA 510(k) K032887 Active Cleared 19 Dec 2003

• Early Cleavage Medium (Ecm)

  Class II

  FDA 510(k) K033462 Active Cleared 15 Jan 2004

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