FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GSP NEONATAL TOTAL GALACTOSE KIT
K Number: K133652
·
Decision Apr 28, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
8
Applicant Total
3
Review Days
152
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Basic Information
- Device Name
- GSP NEONATAL TOTAL GALACTOSE KIT
- K Number
- K133652
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1310
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Date Received
- November 27, 2013
- Decision Date
- April 28, 2014
- Product Code
- JIA
- 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 |
|---|---|---|---|
| JIA | Enzymatic Methods, Galactose | FDA class 1 | Clinical Chemistry |
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