The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag T4 Chemiluminescence Assay.
| Device ID | K911985 |
| 510k Number | K911985 |
| Device Name: | LUMATAG T4 CHEMILUMINESCENCE ASSAY |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Contact | Ramakrishnan |
| Correspondent | Ramakrishnan LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-06 |
| Decision Date | 1991-08-02 |