510(k) K092273
K092273 is an FDA 510(k) premarket notification submitted by Randox Laboratories, Ltd. for the device "RANDOX ETHANOL ASSAY". The FDA issued a decision of Substantially Equivalent on November 1, 2010. The device falls under product code DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Randox Laboratories, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2010
- Date Received
- July 28, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- Device Class
- Class II
- Regulation Number
- 862.3040
- Review Panel
- TX
- Submission Type