FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
K Number: K153544
·
Decision Jul 25, 2016
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
3
Review Days
227
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Basic Information
- Device Name
- cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
- K Number
- K153544
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Iquum, Inc.
- Date Received
- December 11, 2015
- Decision Date
- July 25, 2016
- 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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