FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇿 Czechia
ACTIVE® Free Testosterone RIA
K Number: K191350
·
Decision Dec 20, 2019
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
87
Applicant Total
1
Review Days
214
Basic Information
- Device Name
- ACTIVE® Free Testosterone RIA
- K Number
- K191350
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunotech s.r.o.
- Date Received
- May 20, 2019
- Decision Date
- December 20, 2019
- 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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