VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Visual, Pregnancy Hcg, Prescription Use

VITEK SYSTEMS, INC.

The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Vitek Immunodiagnostic Assay System.

Pre-market Notification Details

Device IDK921302
510k NumberK921302
Device Name:VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
ContactCheryl Winters-heard
CorrespondentCheryl Winters-heard
VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-19
Decision Date1992-07-28

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