510(k) K923783
K923783 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "ETHYL ALCOHOL ASSAY". The FDA issued a decision of Substantially Equivalent on January 21, 1993. The device falls under product code DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet), a Class II device regulated under 21 CFR 862.3040. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1993
- Date Received
- July 28, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
- Device Class
- Class II
- Regulation Number
- 862.3040
- Review Panel
- TX
- Submission Type