FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMDX VANR FOR ABBOTT M2000
K Number: K123753
·
Decision Jul 17, 2013
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
4
Review Days
223
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Basic Information
- Device Name
- IMDX VANR FOR ABBOTT M2000
- K Number
- K123753
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.1640
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intelligent Medical Devices, Inc.
- Date Received
- December 6, 2012
- Decision Date
- July 17, 2013
- Product Code
- NIJ
- 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 |
|---|---|---|---|
| NIJ | System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species | FDA class 2 | Microbiology |
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