CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK— 510(k) K830563
Substantially EquivalentSorin Biomedica, Fiat, USA, Inc.
FDA 510(k) clearance K830563 for CORTISOL RADIOIMMUNOASSAY KIT-CORTCTK, Substantially Equivalent on 1983-05-13. Applicant: Sorin Biomedica, Fiat, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Product code
- Code CGR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1205
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CGR
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