The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Tsh Chemiluminescence Immuno. Assay.
| Device ID | K881443 |
| 510k Number | K881443 |
| Device Name: | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Contact | Chip Whitacre |
| Correspondent | Chip Whitacre LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie, MN 55344 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-05 |
| Decision Date | 1988-05-27 |