HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
FDA 510(k) clearance K063498 · decided 2007-06-11
Clearance details
- K-number
- K063498
- Device name
- HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2006-11-20
- Decision date
- 2007-06-11
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- OBZ
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Great Neck, NY, 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 |
|---|---|---|
| SPIFE A1AT kit (K213396) | Helena Laboratories, Corp. | 2022-10-13 |
Recalls involving this device
No recalls on record reference this clearance.