510(k) K082248
K082248 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER". The FDA issued a decision of Substantially Equivalent on December 12, 2008. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2008
- Date Received
- August 8, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type