FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
K Number: K955042
·
Decision Dec 13, 1995
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
69
Applicant Total
5
Review Days
40
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Basic Information
- Device Name
- CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
- K Number
- K955042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Shared Systems, Inc.
- Date Received
- November 3, 1995
- Decision Date
- December 13, 1995
- 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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Other Clearances by Shared Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973457 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800 | Jan 2, 1998 | Substantially Equivalent |
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM | Oct 17, 1995 | Substantially Equivalent |
| K953261 | CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM | Aug 15, 1995 | Substantially Equivalent |
| K920212 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM | Aug 20, 1992 | Substantially Equivalent |