510(k) K872180
K872180 is an FDA 510(k) premarket notification submitted by American Monitor Corp. for the device "KINETIC 610 ETHANOL". The FDA issued a decision of Substantially Equivalent on July 7, 1987. 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. American Monitor Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1987
- Date Received
- June 8, 1987
- 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