FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
IMMULITE® 2000 BR-MA
K Number: K233946
·
Decision Mar 13, 2024
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
27
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- IMMULITE® 2000 BR-MA
- K Number
- K233946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics Products, Ltd.
- Date Received
- December 14, 2023
- Decision Date
- March 13, 2024
- Product Code
- MOI
- 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 |
|---|---|---|---|
| MOI | System, Test, Immunological, Antigen, Tumor | FDA class 2 | Immunology |
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