FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMDX FLU A/B AND RSV FOR ABBOTT M2000
K Number: K131584
·
Decision Aug 21, 2013
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
78
Applicant Total
4
Review Days
82
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Basic Information
- Device Name
- IMDX FLU A/B AND RSV FOR ABBOTT M2000
- K Number
- K131584
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intelligent Medical Devices, Inc.
- Date Received
- May 31, 2013
- Decision Date
- August 21, 2013
- Product Code
- OCC
- 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 |
|---|---|---|---|
| OCC | Respiratory Virus Panel Nucleic Acid Assay System | FDA class 2 | Microbiology |
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