510(k) K082488
K082488 is an FDA 510(k) premarket notification submitted by General Atomics for the device "DIAZYME LP(A) ASSAY". The FDA issued a decision of Substantially Equivalent on January 13, 2009. The device falls under product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5600. General Atomics has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2009
- Date Received
- August 28, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lipoprotein, Low-Density, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5600
- Review Panel
- IM
- Submission Type