510(k) K061803
K061803 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA - CONTROL LA 1+2". The FDA issued a decision of Substantially Equivalent on Jul 28, 2006. The device falls under product code GGC (Control, Plasma, Abnormal), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago, Inc. has 21 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 28, 2006
- Date Received
- Jun 27, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Control, Plasma, Abnormal
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type
- 510(k) Exempt