FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Great Basin Shiga Toxin Direct Test
K Number: K152955
·
Decision Mar 22, 2016
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
4
Review Days
167
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Basic Information
- Device Name
- Great Basin Shiga Toxin Direct Test
- K Number
- K152955
- 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
- October 7, 2015
- Decision Date
- March 22, 2016
- Product Code
- PCH
- 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 |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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