FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FilmArray 2.0 System
K Number: K143178
·
Decision Jan 30, 2015
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
28
Review Days
87
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Basic Information
- Device Name
- FilmArray 2.0 System
- K Number
- K143178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biofire Diagnostics, LLC
- Date Received
- November 4, 2014
- Decision Date
- January 30, 2015
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
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| K222601 | FilmArray Pneumonia Panel plus | Oct 27, 2022 | Substantially Equivalent |
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