The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(r) Fsh Chemiluminescence Immunometri Assay.
| Device ID | K905814 |
| 510k Number | K905814 |
| Device Name: | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Contact | Beheshti, Ph.d. |
| Correspondent | Beheshti, Ph.d. LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-28 |
| Decision Date | 1991-02-04 |