System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays

Device Code: 4918

Product Code(s): NTH

Device Classification Information

• Device Type ID: 4918
• Device Name: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
• Regulation Description: Automated Fluorescence In Situ Hybridization (FISH) Enumeration Systems.
• Regulation Medical Specialty: Immunology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.4700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NTH
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 4918
• Device: System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
• Product Code: NTH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Fluorescence In Situ Hybridization (FISH) Enumeration Systems.
• CFR Regulation Number: 866.4700 [🔎]

Premarket Reviews
Manufacturer	Decision
BIOVIEW LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Operates Differently Than Expected	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:57:30