510(k) K780303
K780303 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "AUTO ISO-FILTER COLLECTION TUBE CAP". The FDA issued a decision of Substantially Equivalent on March 30, 1978. The device falls under product code GJE (Tray, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 1978
- Date Received
- February 23, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type