Great Basin Bordetella Direct Test
FDA 510(k) clearance K170284 · decided 2017-03-31
Clearance details
- K-number
- K170284
- Device name
- Great Basin Bordetella Direct Test
- Applicant
- Great Basin Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-01-30
- Decision date
- 2017-03-31
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OZZ
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.