510(k) K072609

SINGLE STEP MEDIUM by Irvine Scientific Sales Co., Inc. — Product Code MQL

K072609 is an FDA 510(k) premarket notification submitted by Irvine Scientific Sales Co., Inc. for the device "SINGLE STEP MEDIUM". The FDA issued a decision of Substantially Equivalent on February 12, 2008. 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
February 12, 2008
Date Received
September 17, 2007
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