510(k) K071711
K071711 is an FDA 510(k) premarket notification submitted by Techlab Inc., Corporate Research Center for the device "ASCA-CHEK". The FDA issued a decision of Substantially Equivalent on November 7, 2007. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Techlab Inc., Corporate Research Center has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2007
- Date Received
- June 22, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Device Class
- Class II
- Regulation Number
- 866.5785
- Review Panel
- IM
- Submission Type