HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G

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

MRL DIAGNOSTICS

The following data is part of a premarket notification filed by Mrl Diagnostics with the FDA for Hsv-1 & Hsv-2 Differentiation Immunoblot Igg, Model Ib0900g.

Pre-market Notification Details

Device IDK000238
510k NumberK000238
Device Name:HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
ClassificationEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
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 CodeLGC  
CFR Regulation Number866.3305 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-01-27
Decision Date2000-04-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20816101021004 K000238 000

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