510(k) K093848
K093848 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "PT-MULTI-CALIBRATOR, MODEL OPAT07". The FDA issued a decision of Substantially Equivalent on December 20, 2010. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2010
- Date Received
- December 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plasma, Coagulation Control
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type