Stainer, Tissue, Automated

Device Code: 5009

Product Code(s): KEY

Device Classification Information

• Device Type ID: 5009
• Device Name: Stainer, Tissue, Automated
• Regulation Description: Automated Slide Stainer.
• 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: 864.3800 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: KEY
• GMP Exempt: No
• 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: 5009
• Device: Stainer, Tissue, Automated
• Product Code: KEY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Automated Slide Stainer.
• CFR Regulation Number: 864.3800 [🔎]

Device Problems
Fluid Leak	1
Temperature Problem	1
Failure To Adhere Or Bond	1
Sparking	1
Total Device Problems	4

TPLC Last Update: 2019-04-02 20:58:48