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510(k) K022931

HYALURONIDASE SOLUTION by Irvine Scientific Sales Co., Inc. — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2002
Date Received
September 4, 2002
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

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  • 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)

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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)
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