IS-VZU IGG TEST SYSTEM

Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is-vzu Igg Test System.

Pre-market Notification Details

Device IDK981867
510k NumberK981867
Device Name:IS-VZU IGG TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Varicella-zoster
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynn Stirling
CorrespondentLynn Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLFY  
CFR Regulation Number866.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-28
Decision Date1998-09-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020228 K981867 000
B3507203800 K981867 000

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