FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GSP NEONATAL THYROXINE (T4)
K Number: K103484
·
Decision Apr 22, 2011
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
85
Applicant Total
3
Review Days
147
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Basic Information
- Device Name
- GSP NEONATAL THYROXINE (T4)
- K Number
- K103484
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Date Received
- November 26, 2010
- Decision Date
- April 22, 2011
- Product Code
- KLI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | FDA class 2 | Clinical Chemistry |
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