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510(k) K061360

NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) by Lab Vision Corp. — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2006
Date Received
May 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunohistochemistry Antibody Assay, Estrogen Receptor
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

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