510(k) K100307
K100307 is an FDA 510(k) premarket notification submitted by Sebia for the device "GELSCAN, MODEL 1206". The FDA issued a decision of Substantially Equivalent on August 31, 2010. The device falls under product code CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes), a Class II device regulated under 21 CFR 862.1445. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 2010
- Date Received
- February 3, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic, Lactate Dehydrogenase Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1445
- Review Panel
- CH
- Submission Type