E. COLI 0157 ELISA STOOL ASSAY

Antigens, All Types, Escherichia Coli

LMD LABORATORIES

The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for E. Coli 0157 Elisa Stool Assay.

Pre-market Notification Details

Device IDK942705
510k NumberK942705
Device Name:E. COLI 0157 ELISA STOOL ASSAY
ClassificationAntigens, All Types, Escherichia Coli
Applicant LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad,  CA  92008
ContactDave Lambillotte
CorrespondentDave Lambillotte
LMD LABORATORIES 2792 LOKER AVE., WEST, #103 SUITE 103 Carlsbad,  CA  92008
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-08
Decision Date1995-09-27

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