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510(k) K092667

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT by Genx Intl., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2010
Date Received
August 31, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Reproductive
Device Class
Class II
Regulation Number
884.6180
Review Panel
OB
Submission Type

Other clearances by Genx Intl., Inc.

  • K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 (January 14, 2011)
  • K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT (April 5, 2010)
  • K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (April 24, 2009)
  • K070689 — LG SPERM FREEZING (July 3, 2007)
  • K020560 — WORKBENCH BY <GENX> (June 19, 2002)
  • K962816 — SPERM PREPARATION MEDIA (November 26, 1996)
  • K963031 — GENXCATHETER (October 21, 1996)

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  • K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) (April 10, 2025)
  • K242107 — CaseMONO™ Culture (CMON); CaseMONO™ w/HEPES (WHMO); CaseBioscience® HTF (HTFC); (March 21, 2025)
  • K241833 — V-GRAD (March 21, 2025)
  • K242043 — Sperm Freezing Medium (January 8, 2025)