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510(k) K160006

Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw Kit by Irvine Scientific — Product Code MQL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2016
Date Received
January 4, 2016
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

  • K914541 — SPERM MAINTENANCE MEDIUM WITH GLYCEROL (February 3, 1994)
  • K900316 — MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES (April 16, 1990)
  • K894405 — HTF WITH ALBUMIN (CATALOG NO. 9994) (September 22, 1989)
  • K894432 — MODIFIED HAM'S F-10 W/ALBUMIN (September 22, 1989)
  • K874668 — SPERM WASHING MEDIUM #9983 & MODIFIED #9984 (March 31, 1988)
  • K872088 — FREEZING MEDIUM (TEST YOLK BUFFER W/GLYCEROL) (August 14, 1987)
  • K872203 — CAT. #9972 REFRIGERATION MEDIUM (TEST YOLK BUFFER) (August 14, 1987)
  • K872102 — SPERM WASHING MEDIUM #9932 (July 16, 1987)
  • K871577 — HTF MEDIUM AND MODIFIED HTF MEDIUM-HEPES (July 15, 1987)
  • K861188 — SPERM CAPACITATION MEDIUM (January 6, 1987)

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