FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solana Strep Complete Assay
K Number: K162274
·
Decision Oct 25, 2016
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
13
Applicant Total
37
Review Days
74
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Basic Information
- Device Name
- Solana Strep Complete Assay
- K Number
- K162274
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2680
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- August 12, 2016
- Decision Date
- October 25, 2016
- Product Code
- PGX
- 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 |
|---|---|---|---|
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | FDA class 2 | Microbiology |
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