510(k) K951536
K951536 is an FDA 510(k) premarket notification submitted by Sebia for the device "HYDRAGEL PROTEIN(E) KIT". The FDA issued a decision of Substantially Equivalent on June 30, 1995. The device falls under product code CEF (Electrophoretic, Protein Fractionation), a Class I device regulated under 21 CFR 862.1630. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1995
- Date Received
- April 3, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic, Protein Fractionation
- Device Class
- Class I
- Regulation Number
- 862.1630
- Review Panel
- CH
- Submission Type