FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Elecsys Testosterone II
K Number: K211685
·
Decision May 6, 2022
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
87
Applicant Total
158
Review Days
338
Basic Information
- Device Name
- Elecsys Testosterone II
- K Number
- K211685
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics
- Date Received
- June 2, 2021
- Decision Date
- May 6, 2022
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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