FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K Number: K201256
·
Decision Nov 4, 2022
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
1
Review Days
907
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
- K Number
- K201256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Procise Diagnostics
- Date Received
- May 11, 2020
- Decision Date
- November 4, 2022
- Product Code
- DCK
- 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 |
|---|---|---|---|
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DCK), ordered by most recent decision date.
K-ASSAY CRP (Ver.2)
FDA 510(k)
FDA Class 2
·Immunology
Yumizen C1200 CRP
FDA 510(k)
FDA Class 2
·Immunology
CRP Vario
FDA 510(k)
FDA Class 2
·Immunology
Yumizen C1200 CRP
FDA 510(k)
FDA Class 2
·Immunology
VITROS Chemistry Products hsCRP Reagent
FDA 510(k)
FDA Class 2
·Immunology
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
FDA 510(k)
FDA Class 2
·Immunology