510(k) K052697
K052697 is an FDA 510(k) premarket notification submitted by Akers Biosciences, Inc. for the device "HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL". The FDA issued a decision of Substantially Equivalent on January 4, 2006. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Akers Biosciences, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2006
- Date Received
- September 28, 2005
- 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