FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
K Number: K071649
·
Decision Aug 7, 2008
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
8
Applicant Total
22
Review Days
416
Basic Information
- Device Name
- NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B
- K Number
- K071649
- 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
- Date Received
- June 18, 2007
- Decision Date
- August 7, 2008
- 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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