510(k) K041799
K041799 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics, Inc. for the device "VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS". The FDA issued a decision of Substantially Equivalent on August 25, 2004. 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. Ortho-Clinical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2004
- Date Received
- July 2, 2004
- Clearance Type
- Traditional
- 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.