510(k) K091283
K091283 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPILLARYS NEONAT HB (PN 2006)". The FDA issued a decision of Substantially Equivalent on February 22, 2010. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2010
- Date Received
- May 1, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Abnormal Hemoglobin Quantitation
- Device Class
- Class II
- Regulation Number
- 864.7415
- Review Panel
- HE
- Submission Type