DIAMEDIX IS-MEASLES IGG TEST SYSTEM

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

DIAMEDIX CORP.

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

Pre-market Notification Details

Device IDK974552
510k NumberK974552
Device Name:DIAMEDIX IS-MEASLES IGG TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubeola Igg
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLJB  
CFR Regulation Number866.3520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-12-04
Decision Date1998-01-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020303 K974552 000
B3507205200 K974552 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.