510(k) K032279
K032279 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ONLINE TDM AMIKA". The FDA issued a decision of Substantially Equivalent on October 10, 2003. The device falls under product code KLP (Amikacin Serum Assay), a Class II device regulated under 21 CFR 862.3035. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2003
- Date Received
- July 24, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amikacin Serum Assay
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type