Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
FDA 510(k) K181438 · Diazyme Laboratories, Inc.
510(k) numberK181438
Submission
- Device name
- Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
- Applicant
- Diazyme Laboratories, Inc.
Poway, CA, US - Received
- June 1, 2018
- Decision date
- June 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code DFH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K193047 | N Latex FLC kappa, N Latex FLC lambdaDFH · Traditional | Siemens Healthcare Diagnostics Products GmbH | 07/14/2021SE |
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| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | 06/16/2026SE |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M… · Traditional | 04/24/2026SE |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | 12/19/2025SE |
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | 08/01/2025SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 08/04/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | 12/13/2021SE |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special | 08/06/2021SE |
| K180209 | Diazyme 1,5-AG AssayNOZ · Traditional | 10/04/2018SE |
| K180074 | Diazyme Lipoprotein (a) AssayDFC · Traditional | 03/22/2018SE |
Questions and answers
When was Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay cleared by the FDA?
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay (K181438) received a 510(k) decision of Substantially Equivalent on June 26, 2018, 25 days after the submission was received.
What is the product code of K181438?
The FDA product code is DFH – Kappa, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.