VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
FDA 510(k) clearance K061483 · decided 2006-08-14
Clearance details
- K-number
- K061483
- Device name
- VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES
- Applicant
- Greiner Bio-One North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-30
- Decision date
- 2006-08-14
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- FMI
- Device class
- 2
- Regulation number
- 880.5570
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Baldwin, MD, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Greiner Bio-One North America
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.