The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Prolactin Chemilumines. Immuno. Assay.
| Device ID | K880296 |
| 510k Number | K880296 |
| Device Name: | LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| 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 | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-25 |
| Decision Date | 1988-03-24 |