510(k) K112120
K112120 is an FDA 510(k) premarket notification submitted by Diazyme Laboratories for the device "DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET". The FDA issued a decision of Substantially Equivalent on January 24, 2013. The device falls under product code GHH (Fibrin Split Products), a Class II device regulated under 21 CFR 864.7320. Diazyme Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2013
- Date Received
- July 25, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrin Split Products
- Device Class
- Class II
- Regulation Number
- 864.7320
- Review Panel
- HE
- Submission Type