DIAMEDIX IS-CMV IGG TEST SYSTEM

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK981163
510k NumberK981163
Device Name:DIAMEDIX IS-CMV IGG TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLFZ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-31
Decision Date1998-09-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020150 K981163 000
B3507203200 K981163 000

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