Microscope, Fluorescence/u.v.

Device Code: 4944

Product Code(s): IBK

Device Classification Information

• Device Type ID: 4944
• Device Name: Microscope, Fluorescence/u.v.
• Regulation Description: Microscopes And Accessories.
• Regulation Medical Specialty: Pathology
• Review Panel: Pathology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.3600 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IBK
• GMP Exempt: Yes
• 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: 4944
• Device: Microscope, Fluorescence/u.v.
• Product Code: IBK
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Microscopes And Accessories.
• CFR Regulation Number: 864.3600 [🔎]

TPLC Last Update: 2019-04-02 20:57:50