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510(k) K083509

LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA by Genx Intl., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2009
Date Received
November 26, 2008
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)
  • 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)

Other clearances for product code MQL

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  • 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)