SPIFE A1AT kit
FDA 510(k) clearance K213396 · decided 2022-10-13
Clearance details
- K-number
- K213396
- Device name
- SPIFE A1AT kit
- Applicant
- Helena Laboratories, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-18
- Decision date
- 2022-10-13
- Days to decision
- 360 days
- Clearance type
- Traditional
- Product code
- OBZ
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) (K063498) | Sebia | 2007-06-11 |
Recalls involving this device
No recalls on record reference this clearance.