HSV-1 ELISA IGG, MODEL EL0910G

Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1

MRL DIAGNOSTICS

The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Hsv-1 Elisa Igg, Model El0910g.

Pre-market Notification Details

Device IDK993754
510k NumberK993754
Device Name:HSV-1 ELISA IGG, MODEL EL0910G
ClassificationEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Applicant MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress,  CA  90630 -4737
ContactMichael J Wagner
CorrespondentMichael J Wagner
MRL DIAGNOSTICS 10703 PROGRESS WAY Cypress,  CA  90630 -4737
Product CodeMXJ  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-05
Decision Date2000-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101022155 K993754 000
20816101022148 K993754 000
10816101022295 K993754 000

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