510(k) K063498
- Device
- HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
- Applicant
- SEBIA
- 510(k) number
- K063498
- Product code
- OBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-11
- Date received
- 2006-11-20
- Regulation
- 866.5130
- Classification name
- Alpha-1-antitrypsin Kit, Qualitative Phenotype
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN ANDERSON
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11001 11001
FDA Registration Numbers#
- 8023024
- 1618982
Source Documents#
Other 510(k) Records For Product Code OBZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213396 | SPIFE A1AT kit | Helena Laboratories, Corp. | 2022-10-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary