510(k) K030428
K030428 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ONLINE TDM PHENYTOIN". The FDA issued a decision of Substantially Equivalent on April 28, 2003. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 2003
- Date Received
- February 10, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Diphenylhydantoin
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type