510(k) K801145
K801145 is an FDA 510(k) premarket notification submitted by Scientific Manufacturing Industries for the device "SMI MULTI-TUBE VORTEXER". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code JRQ (Shaker/Stirrer), 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
- June 9, 1980
- Date Received
- May 13, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shaker/Stirrer
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type