510(k) K063057
K063057 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corporation for the device "IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP". The FDA issued a decision of Substantially Equivalent on December 22, 2006. The device falls under product code NQD (Cardiac C-Reactive Protein, Antigen, Antiserum, And Control), a Class II device regulated under 21 CFR 866.5270. Diagnostic Products Corporation has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2006
- Date Received
- October 5, 2006
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Device Class
- Class II
- Regulation Number
- 866.5270
- Review Panel
- IM
- Submission Type
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.