CHOLINESTERASE REAGENT

Colorimetry, Cholinesterase

GILFORD DIAGNOSTICS

The following data is part of a premarket notification filed by Gilford Diagnostics with the FDA for Cholinesterase Reagent.

Pre-market Notification Details

Device IDK791725
510k NumberK791725
Device Name:CHOLINESTERASE REAGENT
ClassificationColorimetry, Cholinesterase
Applicant GILFORD DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDIH  
CFR Regulation Number862.3240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-31
Decision Date1979-10-17

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