FilmArray Pneumonia/Pneumoniaplus Control— 510(k) K190222
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K190222 for FilmArray Pneumonia/Pneumoniaplus Control, Substantially Equivalent on 2019-05-03. Applicant: Maine Molecular Quality Controls, Inc..
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Code PMN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saco, ME, US
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