FilmArray Warrior Control Panel M290
FDA 510(k) clearance K163522 · decided 2017-03-14
Clearance details
- K-number
- K163522
- Device name
- FilmArray Warrior Control Panel M290
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-15
- Decision date
- 2017-03-14
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- PMN
- Device class
- 2
- Regulation number
- 866.3920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Saco, ME, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.