510(k) K032461
K032461 is an FDA 510(k) premarket notification submitted by Lin-Zhi International, Inc. for the device "ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221". The FDA issued a decision of Substantially Equivalent on October 3, 2003. 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. Lin-Zhi International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2003
- Date Received
- August 11, 2003
- 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