BacterioScan 216Dx System
FDA 510(k) clearance K172412 · decided 2018-05-01
Clearance details
- K-number
- K172412
- Device name
- BacterioScan 216Dx System
- Applicant
- Bacterioscan, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-10
- Decision date
- 2018-05-01
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- QBQ
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.