SPIFE A1AT kit
FDA 510(k) K213396 · Helena Laboratories, Corp.
510(k) numberK213396
Submission
- Device name
- SPIFE A1AT kit
- Applicant
- Helena Laboratories, Corp.
Beaumont, TX, US - Received
- October 18, 2021
- Decision date
- October 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- OBZ – Alpha-1-Antitrypsin Kit, Qualitative Phenotype
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Specialty
- Immunology
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.
Other 510(k)s with product code OBZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063498 | Hydragel 18 A1AT Isofocusing Kit (PN 4356)OBZ · Traditional | Sebia | 06/11/2007SE |
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Questions and answers
When was SPIFE A1AT kit cleared by the FDA?
SPIFE A1AT kit (K213396) received a 510(k) decision of Substantially Equivalent on October 13, 2022, 360 days after the submission was received.
What is the product code of K213396?
The FDA product code is OBZ – Alpha-1-Antitrypsin Kit, Qualitative Phenotype, a Class II (moderate risk) device regulated under 21 CFR 866.5130.