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510(k) K060227

VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) by Vision Biosystems, Inc. — Product Code MYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2006
Date Received
January 30, 2006
Clearance Type
Abbreviated
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

Other clearances by Vision Biosystems, Inc.

  • K062615 — VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (January 29, 2007)

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