N Latex FLC kappa, N Latex FLC lambda
FDA 510(k) K193047 · Siemens Healthcare Diagnostics Products GmbH
510(k) numberK193047
Submission
- Device name
- N Latex FLC kappa, N Latex FLC lambda
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- November 1, 2019
- Decision date
- July 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DFH – Kappa, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | Diazyme Laboratories, Inc. | 12/19/2025SE |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitDFH · Traditional | The Binding Site Group , Ltd. | 05/23/2025SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 02/23/2024SE |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitDFH · Traditional | The Binding Site, Ltd. | 01/24/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | Sebia | 11/18/2022SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | Diazyme Laboratories, Inc. | 08/04/2022SE |
| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/29/2021SE |
| K190879 | N Latex FLC kappa, N Latex FLC lambdaDFH · Special | Siemens Healthcare Diagnostics Products GmbH | 05/03/2019SE |
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| K212379 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 03/02/2022SE |
| K201496 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | 10/29/2021SE |
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Questions and answers
When was N Latex FLC kappa, N Latex FLC lambda cleared by the FDA?
N Latex FLC kappa, N Latex FLC lambda (K193047) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 621 days after the submission was received.
What is the product code of K193047?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.