The following data is part of a premarket notification filed by Cylex, Inc. with the FDA for Immuknow-the Cylex Immune Cellfunction Assay.
| Device ID | K101911 |
| 510k Number | K101911 |
| Device Name: | IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY |
| Classification | Assay, Proliferation, In Vitro, T Lymphocyte |
| Applicant | CYLEX, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Contact | Judi Smith |
| Correspondent | Judi Smith CYLEX, INC. P.O. BOX 103 Baldwin, MD 21013 |
| Product Code | NID |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-09 |
| Decision Date | 2010-10-18 |
| Summary: | summary |