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510(k) K190152

Vit Kit- Freeze NX and Vit Kit- Warm NX by Fujifilm Irvine Scientific, Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2019
Date Received
January 30, 2019
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 Fujifilm Irvine Scientific, Inc.

  • K250445 — Fast Warm - NX (September 12, 2025)
  • K241341 — cryo-GO Vitrification Device (September 26, 2024)
  • K233764 — SSS-NX (Serum Substitute Supplement-NX) (April 24, 2024)
  • K231804 — PRIME-XV FreezIS DMSO-Free MD (November 9, 2023)

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)