E.COLI 0157 LATEX TEST

Antigens, All Types, Escherichia Coli

PRO-LAB DIAGNOSTICS

The following data is part of a premarket notification filed by Pro-lab Diagnostics with the FDA for E.coli 0157 Latex Test.

Pre-market Notification Details

Device IDK944421
510k NumberK944421
Device Name:E.COLI 0157 LATEX TEST
ClassificationAntigens, All Types, Escherichia Coli
Applicant PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario,  CA
ContactLynn Rae
CorrespondentLynn Rae
PRO-LAB DIAGNOSTICS 20 MURAL ST. RICHMOND HILL Ontario,  CA
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-18
Decision Date1994-12-15

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