FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Premier HpSA Flex (619096)
K Number: K230901
·
Decision Jul 3, 2023
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
38
Review Days
94
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Basic Information
- Device Name
- Premier HpSA Flex (619096)
- K Number
- K230901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- March 31, 2023
- Decision Date
- July 3, 2023
- Product Code
- LYR
- 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 |
|---|---|---|---|
| LYR | Helicobacter Pylori | FDA class 1 | Microbiology |
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|---|---|---|---|
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| K222779 | Revogene | Jan 26, 2023 | Substantially Equivalent |
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| K210976 | Curian Campy | Dec 23, 2021 | Substantially Equivalent |
| K192817 | Curian HpSA, Curian Analyzer | Mar 13, 2020 | Substantially Equivalent |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Nov 30, 2018 | Unknown |
| K182559 | PREMIER Platinum HpSA PLUS | Nov 5, 2018 | Substantially Equivalent |
| K163273 | TRU Legionella | Feb 21, 2017 | Substantially Equivalent |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | Jun 13, 2016 | Substantially Equivalent |