Slides, Microscope

Device Code: 5008

Product Code(s): KEW

Device Classification Information

• Device Type ID: 5008
• Device Name: Slides, Microscope
• Regulation Description: Tissue Processing Equipment.
• 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: 864.3010 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KEW
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-166 CLSI GP20-A2 (Replaces GP20-A)
  Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
• 7-259 CLSI GP23-A2 (Replaces GP23-A)
  Nongynecological Cytology Specimens: Preexamination, Examination, And Postexamination Processes; Approved Guideline - Second Edition

Total Product Life Cycle

• Device Type ID: 5008
• Device: Slides, Microscope
• Product Code: KEW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Tissue Processing Equipment.
• CFR Regulation Number: 864.3010 [🔎]

TPLC Last Update: 2019-04-02 20:58:47