POOL NORM— 510(k) K142132
Substantially EquivalentDiagnostics Stago S.A.S.
FDA 510(k) clearance K142132 for POOL NORM, Substantially Equivalent on 2014-12-12. Applicant: Diagnostics Stago S.A.S.. Device class: 2.
Clearance details
- Applicant
- Diagnostics Stago S.A.S.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gennevilliers, FR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.