FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
K Number: K053335
·
Decision Mar 10, 2006
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
90
Applicant Total
38
Review Days
99
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Basic Information
- Device Name
- PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
- K Number
- K053335
- 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
- December 1, 2005
- Decision Date
- March 10, 2006
- 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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| K220480 | Revogene | Jul 11, 2022 | Substantially Equivalent |
| K210976 | Curian Campy | Dec 23, 2021 | Substantially Equivalent |
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| 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 |