510(k) K874382
K874382 is an FDA 510(k) premarket notification submitted by Reagents Applications, Inc. for the device "RAICHEM(TM) ALCOHOL REAGENT". The FDA issued a decision of Substantially Equivalent on January 11, 1988. 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. Reagents Applications, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1988
- Date Received
- October 26, 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