TRICYCLIC ANTIDEPRESSANTS I TX CONTROL

Drug Mixture Control Materials

UTAK LABORATORIES, INC.

The following data is part of a premarket notification filed by Utak Laboratories, Inc. with the FDA for Tricyclic Antidepressants I Tx Control.

Pre-market Notification Details

Device IDK800888
510k NumberK800888
Device Name:TRICYCLIC ANTIDEPRESSANTS I TX CONTROL
ClassificationDrug Mixture Control Materials
Applicant UTAK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-17
Decision Date1980-05-02

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