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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NYQ PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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INFORM HER2 Dual ISH DNA Probe Cocktail VENTANA MEDICAL SYSTEMS, INC. P100027 S041 01/26/2024
VENTANA HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc. P190031 S010 01/26/2024
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