DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM

Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Diamedix Is-hsv 1 & 2 Igg Test System.

Pre-market Notification Details

Device IDK981306
510k NumberK981306
Device Name:DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
ClassificationEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling
CorrespondentLynne Stirling
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLGC  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-10
Decision Date1998-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020174 K981306 000

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