510(k) K923337
K923337 is an FDA 510(k) premarket notification submitted by Toxi-Lab, Inc. for the device "ON*SITE ALCOHOL". The FDA issued a decision of Substantially Equivalent on January 12, 1993. The device falls under product code DML (Nad-Nadh, Specific Reagent For Alcohol Enzyme Method), a Class II device regulated under 21 CFR 862.3040. Toxi-Lab, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1993
- Date Received
- June 18, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device Class
- Class II
- Regulation Number
- 862.3040
- Review Panel
- TX
- Submission Type