FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
K Number: K103209
·
Decision Jan 10, 2011
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
77
Applicant Total
1
Review Days
70
Basic Information
- Device Name
- VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
- K Number
- K103209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NANOSPHERE, INC.
- Date Received
- November 1, 2010
- Decision Date
- January 10, 2011
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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