510(k) K840186
K840186 is an FDA 510(k) premarket notification submitted by Scientific Manufacturing Industries for the device "SMI DIGITRON". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code JRC (Micro Pipette), a Class I device regulated under 21 CFR 862.2050. Scientific Manufacturing Industries has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1984
- Date Received
- January 18, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micro Pipette
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type