Isolate, Isolate Concentrate, Isolate Stock Solution

• • Ongoing Z-0998-2024 FDA Class II ·initiated 2 Nov 2023

  The lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686, Shelf Life: 31 December 2024) but incorrectly may contain lower layer (Lot number 9925811106, Shelf Life: 30 November 2023).

510(k) Number

K991341 ↗

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

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

  Class II

  FDA 510(k) K003278 Active Cleared 17 Jan 2001

• Phenol Red Stock Solution

  Class II

  FDA 510(k) K032887 Active Cleared 19 Dec 2003

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