The following data is part of a premarket notification filed by Helena Laboratories, Corp. with the FDA for Spife A1at Kit.
| Device ID | K213396 |
| 510k Number | K213396 |
| Device Name: | SPIFE A1AT Kit |
| Classification | Alpha-1-antitrypsin Kit, Qualitative Phenotype |
| Applicant | Helena Laboratories, Corp. 1530 Lindbergh Drive Beaumont, TX 77707 |
| Contact | Rachel Easley |
| Correspondent | Rachel Easley Helena Laboratories, Corp. 1530 Lindbergh Drive Beaumont, TX 77707 |
| Product Code | OBZ |
| CFR Regulation Number | 866.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-18 |
| Decision Date | 2022-10-13 |