FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRISMA C-REACTIVE PROTEIN CONTROLS
K Number: K823415
·
Decision Dec 9, 1982
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
125
Applicant Total
448
Review Days
24
Basic Information
- Device Name
- PRISMA C-REACTIVE PROTEIN CONTROLS
- K Number
- K823415
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- SYVA CO.
- Date Received
- November 15, 1982
- Decision Date
- December 9, 1982
- Product Code
- DCK
- Advisory Committee
- Immunology
- Review Advisory Committee
- CH
- 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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| K011528 | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | Jun 6, 2001 | Substantially Equivalent |
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