510(k) K771523
K771523 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "LATELET RETENTION COLUMN". The FDA issued a decision of Substantially Equivalent on November 22, 1977. The device falls under product code JBZ (Study, Platelet Adhesive), a Class II device regulated under 21 CFR 864.6650. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 22, 1977
- Date Received
- August 8, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Study, Platelet Adhesive
- Device Class
- Class II
- Regulation Number
- 864.6650
- Review Panel
- HE
- Submission Type