Home / 510(k) Clearances / K121572

510(k) K121572

CONTINUOUS SINGLE CULTURE COMPLETE by Irvine Scientific Sales Co., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2012
Date Received
May 29, 2012
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 Irvine Scientific Sales Co., Inc.

  • K171224 — Arctic Sperm Cryopreservation Medium (August 31, 2017)
  • K170681 — Continuous Single Culture -NX (CSCM-NX) (June 8, 2017)
  • K170602 — Continuous Single Culture-NX Complete (CSCM-NXC) (June 7, 2017)
  • K121128 — MULTIPURPOSE HANDLING MEDIUM (June 6, 2012)
  • K093273 — VIT KIT - FREEZE AND THAW (March 3, 2010)
  • K072609 — SINGLE STEP MEDIUM (February 12, 2008)
  • K072608 — LYOPHILIZED MULTIBLAST MEDIUM KIT (January 30, 2008)
  • K072607 — LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT (January 25, 2008)
  • K061549 — AMNIOSTAT-FLM-PG (October 18, 2006)
  • K061679 — WALLACE ARTIFICIAL INSEMINATION CATHETER (October 13, 2006)

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)