DIRIA-PROGK IMMUNOASSAY— 510(k) K832694
Substantially EquivalentSorin Biomedica, Fiat, USA, Inc.
FDA 510(k) clearance K832694 for DIRIA-PROGK IMMUNOASSAY, Substantially Equivalent on 1984-01-11. Applicant: Sorin Biomedica, Fiat, USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Product code
- Code JLS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1620
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JLS
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