FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTODELFIA NEONATAL IRT KIT
K Number: K110274
·
Decision Jun 10, 2011
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
6
Applicant Total
3
Review Days
130
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Basic Information
- Device Name
- AUTODELFIA NEONATAL IRT KIT
- K Number
- K110274
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1725
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.
- Date Received
- January 31, 2011
- Decision Date
- June 10, 2011
- Product Code
- JNO
- 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 |
|---|---|---|---|
| JNO | N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | FDA class 1 | Clinical Chemistry |
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