510(k) K991702
MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 by
Becton Dickinson Vacutainer Systems
— Product Code JKA
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1999
- Date Received
- May 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type