FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Elecsys Folate III
K Number: K233060
·
Decision Jun 17, 2024
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
63
Applicant Total
183
Review Days
266
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Basic Information
- Device Name
- Elecsys Folate III
- K Number
- K233060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1295
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- September 25, 2023
- Decision Date
- June 17, 2024
- Product Code
- CGN
- 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 |
|---|---|---|---|
| CGN | Acid, Folic, Radioimmunoassay | FDA class 2 | Clinical Chemistry |
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