510(k) K071712
K071712 is an FDA 510(k) premarket notification submitted by Techlab Inc., Corporate Research Center for the device "LEUKO EZ VUE". The FDA issued a decision of Substantially Equivalent on December 4, 2007. The device falls under product code DEG (Lactoferrin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5570. Techlab Inc., Corporate Research Center has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2007
- Date Received
- June 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lactoferrin, Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5570
- Review Panel
- IM
- Submission Type