510(k) K083444
K083444 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "C-REACTIVE PROTEIN (LATEX)". The FDA issued a decision of Substantially Equivalent on March 18, 2009. The device falls under product code DCN (System, Test, C-Reactive Protein), a Class II device regulated under 21 CFR 866.5270. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2009
- Date Received
- November 21, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, C-Reactive Protein
- Device Class
- Class II
- Regulation Number
- 866.5270
- Review Panel
- IM
- Submission Type