Great Basin Bordetella Direct Test— 510(k) K170284
Substantially EquivalentGreat Basin Scientific, Inc.
FDA 510(k) clearance K170284 for Great Basin Bordetella Direct Test, Substantially Equivalent on 2017-03-31. Applicant: Great Basin Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Great Basin Scientific, Inc.
- Product code
- Code OZZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
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More clearances from Great Basin Scientific, Inc.
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