Immunoglobulin G (IgG)
FDA 510(k) K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
510(k) numberK221114
Submission
- Device name
- Immunoglobulin G (IgG)
- Applicant
- Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
Suzhou, CN - Received
- April 15, 2022
- Decision date
- August 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFN – Method, Nephelometric, Immunoglobulins (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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|---|---|---|---|
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)CFN · Special | Siemens Healthcare Diagnostics Products GmbH | 12/13/2023SE |
| K192116 | Human IgA liquid reagent kit for Use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 09/04/2019SE |
| K191985 | Optilite IgA KitCFN · Special | The Binding Site Group , Ltd. | 08/19/2019SE |
| K191635 | Optilite IgM KitCFN · Special | The Binding Site Group , Ltd. | 07/15/2019SE |
| K191465 | Human IgM Kit for use on SPAPlusCFN · Special | The Binding Site Group , Ltd. | 06/27/2019SE |
| K190686 | Optilite IgM CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 05/28/2019SE |
| K183151 | Optilite IgA CSF KitCFN · Traditional | The Binding Site Group , Ltd. | 01/23/2019SE |
| K162208 | DxC 700 AU Clinical Chemistry Analyzer, AU IgG ReagentCFN · Traditional | Beckman Coulter, Inc. | 01/09/2017SE |
| K150526 | Optilite IgG4 KitCFN · Traditional | The Binding Site Group , Ltd. | 05/30/2015SE |
| K142735 | The Optilite IgG3 kitCFN · Traditional | The Binding Site Group , Ltd. | 12/21/2014SE |
More from The Binding Site Group , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K220977 | ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry AnalyzerJGS · Traditional | 07/20/2023SE |
Questions and answers
When was Immunoglobulin G (IgG) cleared by the FDA?
Immunoglobulin G (IgG) (K221114) received a 510(k) decision of Substantially Equivalent on August 2, 2023, 474 days after the submission was received.
What is the product code of K221114?
The FDA product code is CFN – Method, Nephelometric, Immunoglobulins (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.