FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
GenePOC GBS LB
K Number: K170557
·
Decision May 25, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
17
Applicant Total
5
Review Days
90
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Basic Information
- Device Name
- GenePOC GBS LB
- K Number
- K170557
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genepoc, Inc.
- Date Received
- February 24, 2017
- Decision Date
- May 25, 2017
- Product Code
- NJR
- 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 |
|---|---|---|---|
| NJR | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test | FDA class 1 | Microbiology |
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