CAPILLARYS NEONAT HB (PN 2006)
FDA 510(k) clearance K091283 · decided 2010-02-22
Clearance details
- K-number
- K091283
- Device name
- CAPILLARYS NEONAT HB (PN 2006)
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2009-05-01
- Decision date
- 2010-02-22
- Days to decision
- 297 days
- Clearance type
- Traditional
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sebia
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.