VACUTAINER PLUS TUBES
FDA 510(k) clearance K953463 · decided 1995-09-20
Clearance details
- K-number
- K953463
- Device name
- VACUTAINER PLUS TUBES
- Applicant
- Becton Dickinson Vacutainer Systems
- Decision
- Substantially Equivalent
- Date received
- 1995-07-24
- Decision date
- 1995-09-20
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lake, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.