Filters, Cell Collection, Tissue Processing

Device Code: 5007

Product Code(s): KET

Device Classification Information

• Device Type ID: 5007
• Device Name: Filters, Cell Collection, Tissue Processing
• 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: KET
• 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: 5007
• Device: Filters, Cell Collection, Tissue Processing
• Product Code: KET
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Tissue Processing Equipment.
• CFR Regulation Number: 864.3010 [🔎]

TPLC Last Update: 2019-04-02 20:58:46