FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
CRP-LATEX (II)X2 SEIKEN ASSAY KIT
K Number: K030545
·
Decision Jun 2, 2003
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
125
Applicant Total
6
Review Days
102
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Basic Information
- Device Name
- CRP-LATEX (II)X2 SEIKEN ASSAY KIT
- K Number
- K030545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Denka Seiken Co., Ltd.
- Date Received
- February 20, 2003
- Decision Date
- June 2, 2003
- 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 |
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Other Clearances by Denka Seiken Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K161679 | s LDL-EX SEIKEN | Aug 18, 2017 | Substantially Equivalent |
| K060359 | ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 | Apr 14, 2006 | Substantially Equivalent |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Jan 26, 2005 | Substantially Equivalent |
| K041090 | HDL-EX SEIKEN ASSAY KIT | Oct 29, 2004 | Substantially Equivalent |
| K030546 | CRP (II) CALIBRATORS | Jun 2, 2003 | Substantially Equivalent |