ATYPICAL CHOLINESTERASE

Colorimetry, Cholinesterase

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Atypical Cholinesterase.

Pre-market Notification Details

Device IDK873496
510k NumberK873496
Device Name:ATYPICAL CHOLINESTERASE
ClassificationColorimetry, Cholinesterase
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactDebra Hofmeister
CorrespondentDebra Hofmeister
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeDIH  
CFR Regulation Number862.3240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-18
Decision Date1989-01-27

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