510(k) K093273

VIT KIT - FREEZE AND THAW by Irvine Scientific Sales Co., Inc. — Product Code MQL

K093273 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "VIT KIT - FREEZE AND THAW". The FDA issued a decision of Substantially Equivalent on March 3, 2010. 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
March 3, 2010
Date Received
October 19, 2009
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