VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)

Igg, Antigen, Antiserum, Control

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 (vidas).

Pre-market Notification Details

Device IDK891385
510k NumberK891385
Device Name:VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)
ClassificationIgg, Antigen, Antiserum, Control
Applicant VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
ContactJoan L Metcalf
CorrespondentJoan L Metcalf
VITEK SYSTEMS, INC. 595 ANGLUM DR. Hazelwood,  MI  63042 -2395
Product CodeDEW  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-09
Decision Date1989-04-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026152482 K891385 000
03573026140427 K891385 000
03573026619527 K891385 000

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