FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K Number: K113809
·
Decision Aug 17, 2012
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
16
Review Days
238
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Basic Information
- Device Name
- HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
- K Number
- K113809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hitachi Chemical Diagnostics, Inc.
- Date Received
- December 23, 2011
- Decision Date
- August 17, 2012
- 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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