CHOLINESTERASE

Colorimetry, Cholinesterase

J. D. ASSOC.

The following data is part of a premarket notification filed by J. D. Assoc. with the FDA for Cholinesterase.

Pre-market Notification Details

Device IDK863111
510k NumberK863111
Device Name:CHOLINESTERASE
ClassificationColorimetry, Cholinesterase
Applicant J. D. ASSOC. 163 MONTCLAIR AVE. Montclair,  NJ  07042
ContactDi Pietro
CorrespondentDi Pietro
J. D. ASSOC. 163 MONTCLAIR AVE. Montclair,  NJ  07042
Product CodeDIH  
CFR Regulation Number862.3240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-13
Decision Date1986-09-11

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