FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
K Number: K043067
·
Decision May 31, 2005
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
179
Applicant Total
1
Review Days
204
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Basic Information
- Device Name
- ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
- K Number
- K043067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioarray Solutions, Ltd.
- Date Received
- November 8, 2004
- Decision Date
- May 31, 2005
- Product Code
- LLL
- 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | FDA class 2 | Immunology |
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