510(k) K020704
K020704 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "ROCHE ONLINE GENTAMICIN". The FDA issued a decision of Substantially Equivalent on July 12, 2002. The device falls under product code LCD (Enzyme Immunoassay, Gentamicin), a Class II device regulated under 21 CFR 862.3450. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2002
- Date Received
- March 4, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Gentamicin
- Device Class
- Class II
- Regulation Number
- 862.3450
- Review Panel
- TX
- Submission Type