510(k) K092170
K092170 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA LIATEST FREE PS". The FDA issued a decision of Substantially Equivalent on December 22, 2009. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2009
- Date Received
- July 21, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type