510(k) K002564
- Device
- SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K002564
- Product code
- DFH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-26
- Date received
- 2000-08-17
- 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
Related Records
Applicant Contact
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers
- 3003961883
- 3013059683
- 1618982
- 8023024
- 3019906
- 3003423869
- 1649518
- 2083566
- 3009189893
- 2050010
- 9610806
- 2032900
- 9610099
- 2050012
- 3012471076
- 3014271897
- 9681753
- 9614373
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700010146 | Sheep Anti-Human Kappa Free Light Chains Immunofix | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
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 |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | Diazyme Laboratories, Inc. | 2022-08-04 |
| 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 |
Legacy Summary
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases