FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K Number: K173498
·
Decision Aug 13, 2018
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
8
Applicant Total
14
Review Days
273
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Basic Information
- Device Name
- Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- K Number
- K173498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diasorin Molecular, LLC
- Date Received
- November 13, 2017
- Decision Date
- August 13, 2018
- Product Code
- OZZ
- 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 |
|---|---|---|---|
| OZZ | Bordetella Pertussis Dna Assay System | FDA class 2 | Microbiology |
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|---|---|---|---|
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| K220963 | Simplexa COVID-19 & Flu A/B Direct | Mar 17, 2023 | Substantially Equivalent |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Nov 5, 2022 | Substantially Equivalent |
| K212147 | Simplexa COVID-19 Direct | Sep 13, 2022 | Substantially Equivalent |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | Aug 22, 2020 | Substantially Equivalent |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Nov 26, 2019 | Substantially Equivalent |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 | Substantially Equivalent |