510(k) K132555
- Device
- HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
- Applicant
- THE BINDING SITE
- 510(k) number
- K132555
- Product code
- PCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-20
- Date received
- 2013-08-14
- Regulation
- 866.5510
- Classification name
- Immunoglobulin G Kappa Heavy And Light Chain Combined
- 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
- Paul Kenny
- Address
- 8 Calthorpe Rd. Birmingham GB B15 1QT B15 1QT
FDA Registration Numbers
- 3012471076
- 9614373
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05051700016988 | Hevylite IgG Lambda Kit for Siemens BNII | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700016971 | Hevylite IgG Kappa Kit for Siemens BNII | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
Other 510(k) Records For Product Code PCN
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
Decision Summary