510(k) K854406
K854406 is an FDA 510(k) premarket notification submitted by Tecan U.S., Ltd. for the device "TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500". The FDA issued a decision of Substantially Equivalent on February 10, 1986. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Tecan U.S., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1986
- Date Received
- November 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Station, Pipetting And Diluting, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2750
- Review Panel
- CH
- Submission Type