FDA 510(k) Applications for Medical Device:
Alpha-1-Antitrypsin Kit, Qualitative Phenotype
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K213396 | Helena Laboratories, Corp. |
1530 Lindbergh Drive | Beaumont | TX | 77707 |
| K063498 | SEBIA |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11001 |
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