510(k) K032336
K032336 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "TINA-QUANT CRP (LATEX)". The FDA issued a decision of Substantially Equivalent on August 5, 2003. 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
- August 5, 2003
- Date Received
- July 29, 2003
- Clearance Type
- Special
- 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