FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K Number: K171498
·
Decision Jan 12, 2018
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
1
Review Days
234
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Basic Information
- Device Name
- MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
- K Number
- K171498
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meso Scale Diagnostics, LLC
- Date Received
- May 23, 2017
- Decision Date
- January 12, 2018
- Product Code
- DCN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
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