FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GenePOC Strep A
K Number: K183366
·
Decision Mar 6, 2019
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
13
Applicant Total
5
Review Days
92
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Basic Information
- Device Name
- GenePOC Strep A
- K Number
- K183366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2680
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genepoc, Inc.
- Date Received
- December 4, 2018
- Decision Date
- March 6, 2019
- 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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