The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for London Diagnostics Lumatag (r) Ige Chem. Imm Assay.
| Device ID | K903195 |
| 510k Number | K903195 |
| Device Name: | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Contact | Ramakrishman |
| Correspondent | Ramakrishman LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-19 |
| Decision Date | 1990-08-02 |