510(k) K023955
K023955 is an FDA 510(k) premarket notification submitted by Becton, Dickinson & CO for the device "BD VIPER INSTRUMENT". The FDA issued a decision of Substantially Equivalent on June 24, 2003. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Becton, Dickinson & CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2003
- Date Received
- November 27, 2002
- 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