510(k) K813033
K813033 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY". The FDA issued a decision of Substantially Equivalent on April 9, 1982. The device falls under product code GKG (Centrifuge, Hematocrit), a Class II device regulated under 21 CFR 864.6400. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1982
- Date Received
- October 28, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Centrifuge, Hematocrit
- Device Class
- Class II
- Regulation Number
- 864.6400
- Review Panel
- HE
- Submission Type