510(k) K790027
K790027 is an FDA 510(k) premarket notification submitted by Sysmex Corp. for the device "SHAKER, MODEL SH-510". The FDA issued a decision of Substantially Equivalent on February 8, 1979. The device falls under product code JRQ (Shaker/Stirrer), a Class I device regulated under 21 CFR 862.2050. Sysmex Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1979
- Date Received
- January 3, 1979
- 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