LUMATAG(TM) LH DIAGNOSTIC KIT— 510(k) K902443

Name: FDA 510(k) clearance K902443
Creator: U.S. Food and Drug Administration
Published: 1990-08-02

Substantially Equivalent

London Diagnostics, Inc.

FDA 510(k) clearance K902443 for LUMATAG(TM) LH DIAGNOSTIC KIT, Substantially Equivalent on 1990-08-02. Applicant: London Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: London Diagnostics, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1990-06-01
Decision date: 1990-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEP

view all

K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE2003-01-16
K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST2002-11-05
K021409 — AT HOME OVULATION TEST, MODEL 90322002-05-24
K013874 — CLEARPLANE EASY OVULATION TEST2002-02-19
K013323 — TCI-31 LIFELONG OVULATION TESTER2001-12-05

More clearances from London Diagnostics, Inc.

view all

K914835 — LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY1991-12-17
K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY1991-08-02
K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY1991-07-30
K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY1991-02-04
K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION1990-10-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.