THEOPHYLLINE CONTROL SERUM

Drug Specific Control Materials

VITEK SYSTEMS, INC.

The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Theophylline Control Serum.

Pre-market Notification Details

Device IDK780961
510k NumberK780961
Device Name:THEOPHYLLINE CONTROL SERUM
ClassificationDrug Specific Control Materials
Applicant VITEK SYSTEMS, 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 Received1978-06-12
Decision Date1978-12-07

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