FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Immunoglobulin G (IgG)
K Number: K221114
·
Decision Aug 2, 2023
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
60
Applicant Total
2
Review Days
474
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Basic Information
- Device Name
- Immunoglobulin G (IgG)
- K Number
- K221114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5510
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
- Date Received
- April 15, 2022
- Decision Date
- August 2, 2023
- Product Code
- CFN
- 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 |
|---|---|---|---|
| CFN | Method, Nephelometric, Immunoglobulins (G, A, M) | FDA class 2 | Immunology |
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Other Clearances by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer | Jul 20, 2023 | Substantially Equivalent |