The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Ferritin Chemiluminescence Immunomet..
| Device ID | K901075 |
| 510k Number | K901075 |
| Device Name: | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Contact | Ramakrishnan, Phd |
| Correspondent | Ramakrishnan, Phd LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-08 |
| Decision Date | 1990-04-02 |