FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Great Basin Bordetella Direct Test
K Number: K170284
·
Decision Mar 31, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
4
Review Days
60
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Basic Information
- Device Name
- Great Basin Bordetella Direct Test
- K Number
- K170284
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Great Basin Scientific, Inc.
- Date Received
- January 30, 2017
- Decision Date
- March 31, 2017
- Product Code
- OZZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OZZ | Bordetella Pertussis Dna Assay System | FDA class 2 | Microbiology |
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