FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
EasyScreen Gastrointestinal Parasite Detection Kit
K Number: K232672
·
Decision May 29, 2024
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
37
Applicant Total
1
Review Days
271
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Basic Information
- Device Name
- EasyScreen Gastrointestinal Parasite Detection Kit
- K Number
- K232672
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3990
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genetic Signatures Limited
- Date Received
- September 1, 2023
- Decision Date
- May 29, 2024
- Product Code
- PCH
- 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 |
|---|---|---|---|
| PCH | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System | FDA class 2 | Microbiology |
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