NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)

Immunohistochemistry Antibody Assay, Estrogen Receptor

LAB VISION CORP.

The following data is part of a premarket notification filed by Lab Vision Corp. with the FDA for Neomarkers Rabbit Monoclonal Anti-human Estrogen Rece[ptor Antibody (clone Sp1).

Pre-market Notification Details

Device IDK061360
510k NumberK061360
Device Name:NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1)
ClassificationImmunohistochemistry Antibody Assay, Estrogen Receptor
Applicant LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont,  CA  94539
ContactGrace Hsiao-fen Chang
CorrespondentGrace Hsiao-fen Chang
LAB VISION CORP. 47777 WARM SPRINGS BLVD. Fremont,  CA  94539
Product CodeMYA  
CFR Regulation Number864.1860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-16
Decision Date2006-06-27
Summary:summary

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