MONOLISA ANTI-HAV IGM EIA

Hepatitis A Test (antibody And Igm Antibody)

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Monolisa Anti-hav Igm Eia.

Pre-market Notification Details

Device IDK092353
510k NumberK092353
Device Name:MONOLISA ANTI-HAV IGM EIA
ClassificationHepatitis A Test (antibody And Igm Antibody)
Applicant BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond,  WA  98052
ContactLinda Staswick
CorrespondentLinda Staswick
BIO-RAD LABORATORIES, INC. 6565 185TH AVE., N.E. Redmond,  WA  98052
Product CodeLOL  
CFR Regulation Number866.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-04
Decision Date2009-10-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847865012379 K092353 000

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