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510(k) K070689

LG SPERM FREEZING by Genx Intl., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2007
Date Received
March 13, 2007
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)
  • K092667 — GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT (June 3, 2010)
  • K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT (April 5, 2010)
  • K083509 — LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA (April 24, 2009)
  • K020560 — WORKBENCH BY <GENX> (June 19, 2002)
  • K962816 — SPERM PREPARATION MEDIA (November 26, 1996)
  • K963031 — GENXCATHETER (October 21, 1996)

Other clearances for product code MQL

  • K252672 — CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (February 20, 2026)
  • K250445 — Fast Warm - NX (September 12, 2025)
  • K251637 — Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin (August 27, 2025)
  • K251305 — Ultra-Fast Vitri; Ultra-Fast Warm (August 26, 2025)
  • K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentami (May 30, 2025)
  • K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) (April 10, 2025)
  • 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)