510(k) K011113
K011113 is an FDA 510(k) premarket notification submitted by Sebia for the device "HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)". The FDA issued a decision of Substantially Equivalent on June 13, 2001. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2001
- Date Received
- April 11, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type