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510(k) K170602

Continuous Single Culture-NX Complete (CSCM-NXC) by Irvine Scientific Sales Co., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2017
Date Received
March 1, 2017
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)
  • K121572 — CONTINUOUS SINGLE CULTURE COMPLETE (July 19, 2012)
  • 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)

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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)