510(k) K063498
K063498 is an FDA 510(k) premarket notification submitted by Sebia for the device "HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)". The FDA issued a decision of Substantially Equivalent on June 11, 2007. The device falls under product code OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype), a Class II device regulated under 21 CFR 866.5130. Sebia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2007
- Date Received
- November 20, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alpha-1-Antitrypsin Kit, Qualitative Phenotype
- Device Class
- Class II
- Regulation Number
- 866.5130
- Review Panel
- IM
- Submission Type
The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.