510(k) K933088
K933088 is an FDA 510(k) premarket notification submitted by Rosys, Inc. for the device "PLATO 3000". The FDA issued a decision of Substantially Equivalent on February 25, 1994. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Rosys, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1994
- Date Received
- June 23, 1993
- 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