WELLCOLEX COLOUR SALMONELLA TEST ZL 50

Antisera, All Groups, Salmonella Spp.

WELLCOME DIAGNOSTICS

The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Wellcolex Colour Salmonella Test Zl 50.

Pre-market Notification Details

Device IDK890146
510k NumberK890146
Device Name:WELLCOLEX COLOUR SALMONELLA TEST ZL 50
ClassificationAntisera, All Groups, Salmonella Spp.
Applicant WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
ContactMoody, Ph.d.
CorrespondentMoody, Ph.d.
WELLCOME DIAGNOSTICS 3030 CORNWALLIS RD. Research Triangle Park,  NC  27709
Product CodeGRM  
CFR Regulation Number866.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-13
Decision Date1989-02-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05056080500508 K890146 000
05056080500485 K890146 000

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