510(k) K220001
- Device
- Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
- Applicant
- Diazyme Laboratories Inc.
- 510(k) number
- K220001
- Product code
- DFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-08-04
- Date received
- 2022-01-04
- Regulation
- 866.5550
- Classification name
- Kappa, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 3019906
- 9614373
- 2032900
- 9610099
- 3003423869
- 3013059683
- 2083566
- 3012471076
- 9681753
- 3014271897
- 3009189893
- 2050010
- 1618982
- 8023024
- 2050012
- 9610806
- 3003961883
- 1649518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DFH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | Diazyme Laboratories, Inc. | 2025-12-19 |
| K250549 | Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2025-05-23 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | Sebia | 2024-02-23 |
| K231290 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit | The Binding Site, Ltd. | 2024-01-24 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | Sebia | 2022-11-18 |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-09-08 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2022-03-02 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-10-29 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2021-07-14 |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | Siemens Healthcare Diagnostics Products GmbH | 2019-05-03 |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH | 2018-11-01 |
| K173732 | Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit | The Binding Site Group , Ltd. | 2018-08-23 |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2018-06-26 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | Siemens Healthcare Diagnostics Products GmbH | 2017-11-17 |
| K153394 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator | Diazyme Laboratories | 2016-11-18 |
Legacy Summary#
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FDA Review#
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