510(k) K121256
K121256 is an FDA 510(k) premarket notification submitted by Chematics, Inc. for the device "ALCO-SCREEN 02". The FDA issued a decision of Substantially Equivalent on September 12, 2012. 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. Chematics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2012
- Date Received
- April 25, 2012
- 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