FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
K Number: K063498
·
Decision Jun 11, 2007
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
32
Review Days
203
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Basic Information
- Device Name
- HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
- K Number
- K063498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sebia
- Date Received
- November 20, 2006
- Decision Date
- June 11, 2007
- Product Code
- OBZ
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OBZ | Alpha-1-Antitrypsin Kit, Qualitative Phenotype | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OBZ), ordered by most recent decision date.
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