510(k) K093273
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