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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, automated scanning microscope and image analysis for fluorescence in situ hybridization (fish) assays
Product CodeNTH
Regulation Number 866.4700
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED SPECTRAL IMAGING
  SUBSTANTIALLY EQUIVALENT 1
APPLIED SPECTRAL IMAGING, LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOVIEW LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Loss of or Failure to Bond 1 1
Device Operates Differently Than Expected 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Not Applicable 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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