FilmArray BCID2 Control Panel M416— 510(k) K200010
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K200010 for FilmArray BCID2 Control Panel M416, Substantially Equivalent on 2020-04-02. Applicant: Maine Molecular Quality Controls, Inc.. Device class: 2.
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saco, ME, US
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