FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
GenePOC Carba
K Number: K190275
·
Decision May 10, 2019
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
5
Review Days
91
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Basic Information
- Device Name
- GenePOC Carba
- K Number
- K190275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genepoc, Inc.
- Date Received
- February 8, 2019
- Decision Date
- May 10, 2019
- Product Code
- PMY
- 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 |
|---|---|---|---|
| PMY | System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony | FDA class 2 | Microbiology |
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