FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
DELFIA NEONATAL IRT KIT, MODEL A005-110
K Number: K003664
·
Decision Feb 14, 2001
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
37
Applicant Total
22
Review Days
78
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Basic Information
- Device Name
- DELFIA NEONATAL IRT KIT, MODEL A005-110
- K Number
- K003664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wallac OY
- Date Received
- November 28, 2000
- Decision Date
- February 14, 2001
- Product Code
- CGZ
- 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 |
|---|---|---|---|
| CGZ | Electrode, Ion-Specific, Chloride | FDA class 2 | Clinical Chemistry |
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