The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Lh Diagnostic Kit.
| Device ID | K902443 |
| 510k Number | K902443 |
| Device Name: | LUMATAG(TM) LH DIAGNOSTIC KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| 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 | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-01 |
| Decision Date | 1990-08-02 |