LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC

Visual, Pregnancy Hcg, Prescription Use

LONDON DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by London Diagnostics, Inc. with the FDA for Lumatag(tm) Hcg Chemiluminescence Immunometric.

Pre-market Notification Details

Device IDK901484
510k NumberK901484
Device Name:LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie,  MN  55344
ContactRamakrishnan, Phd
CorrespondentRamakrishnan, Phd
LONDON DIAGNOSTICS, INC. 10300 VALLEY VIEW RD. SUITE 107 Eden Prairie,  MN  55344
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-29
Decision Date1990-05-01

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