510(k) K061093
K061093 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "CHOLINESTERASE GEN.2 TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code DIH (Colorimetry, Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2006
- Date Received
- April 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Cholinesterase
- Device Class
- Class I
- Regulation Number
- 862.3240
- Review Panel
- TX
- Submission Type