ACTIVE® Free Testosterone RIA
FDA 510(k) clearance K191350 · decided 2019-12-20
Clearance details
- K-number
- K191350
- Device name
- ACTIVE® Free Testosterone RIA
- Applicant
- Immunotech S.R.O.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-20
- Decision date
- 2019-12-20
- Days to decision
- 214 days
- Clearance type
- Special
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Prague, CZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.