FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Great Basin Stool Bacterial Pathogens Panel
K Number: K163571
·
Decision Jul 12, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
4
Review Days
205
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Basic Information
- Device Name
- Great Basin Stool Bacterial Pathogens Panel
- K Number
- K163571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Great Basin Scientific, Inc.
- Date Received
- December 19, 2016
- Decision Date
- July 12, 2017
- Product Code
- PCI
- 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 |
|---|---|---|---|
| PCI | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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