510(k) K052291
K052291 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPILLARY'S HEMOGLOBIN(E) (PN 2007)". The FDA issued a decision of Substantially Equivalent on June 27, 2006. 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
- June 27, 2006
- Date Received
- August 23, 2005
- 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