K063498 is an FDA 510(k) clearance for the HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356). This device is classified as a Alpha-1-antitrypsin Kit, Qualitative Phenotype (Class II - Special Controls, product code OBZ).
Submitted by Sebia (Great Neck, US). The FDA issued a Cleared decision on June 11, 2007, 203 days after receiving the submission on November 20, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5130. 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..
| 510(k) Number | K063498 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2006 |
| Decision Date | June 11, 2007 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | OBZ — Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5130 |
| Definition | 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. |