510(k) K060168

VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT by Irvine Scientific Sales Co., Inc. — Product Code MQL

K060168 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT". The FDA issued a decision of Substantially Equivalent on April 24, 2006. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Irvine Scientific Sales Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2006
Date Received
January 23, 2006
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