510(k) K101911
- Device
- IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
- Applicant
- CYLEX, INC.
- 510(k) number
- K101911
- Product code
- NID
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-10-18
- Date received
- 2010-07-09
- Regulation
- 864.5220
- Classification name
- Assay, Proliferation, In Vitro, T Lymphocyte
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Judi Smith
- Address
- P.O.Box 103 Baldwin MD US 21013 21013
FDA Registration Numbers#
- 3008434737
Source Documents#
Other 510(k) Records For Product Code NID #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013169 | IMMUNE CELL FUNCTION ASSAY | Cylex, Inc. | 2002-04-02 |
Legacy Summary#
summary
FDA Review#
Decision Summary