510(k) K093879
K093879 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "MISSION SALIVA ALCOHOL TEST STRIP". The FDA issued a decision of Substantially Equivalent on August 6, 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. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 6, 2010
- Date Received
- December 18, 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