FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
K Number: K142033
·
Decision Oct 10, 2014
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
1
Review Days
77
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Basic Information
- Device Name
- VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP)
- K Number
- K142033
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nanospere,Inc.
- Date Received
- July 25, 2014
- Decision Date
- October 10, 2014
- 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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