The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Hcg Chemiluminescence Immunometric.
Device ID | K901484 |
510k Number | K901484 |
Device Name: | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC |
Classification | Visual, Pregnancy Hcg, Prescription Use |
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 | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-29 |
Decision Date | 1990-05-01 |