510(k) K840981
K840981 is an FDA 510(k) premarket notification submitted by Remel Co. for the device "NIACIN REAGENT STRIP". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code MJD (Culture Media, Antimycobacteria, Susceptibility Test), a Class II device regulated under 21 CFR 866.1700. Remel Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1984
- Date Received
- March 6, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimycobacteria, Susceptibility Test
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type