MAPROTILINE

Drug Specific Control Materials

UTAK LABORATORIES, INC.

The following data is part of a premarket notification filed by Utak Laboratories, Inc. with the FDA for Maprotiline.

Pre-market Notification Details

Device IDK831735
510k NumberK831735
Device Name:MAPROTILINE
ClassificationDrug Specific Control Materials
Applicant UTAK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLAS  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-31
Decision Date1983-07-26

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