BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
FDA 510(k) clearance K030573 · decided 2003-05-08
Clearance details
- K-number
- K030573
- Device name
- BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341
- Applicant
- Bd Vacutainer Systems Preanalyical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2003-02-24
- Decision date
- 2003-05-08
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Franklin Lakes, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.