Apparatus, Melting Point, Paraffin

Device Code: 4955

Product Code(s): IDT

Device Classification Information

• Device Type ID: 4955
• Device Name: Apparatus, Melting Point, Paraffin
• 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: IDT
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-164 CLSI GP28-A (Replaces GP28-P)
  Microwave Device Use In The Histology Laboratory; Approved Guideline

Total Product Life Cycle

• Device Type ID: 4955
• Device: Apparatus, Melting Point, Paraffin
• Product Code: IDT
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Tissue Processing Equipment.
• CFR Regulation Number: 864.3010 [🔎]

Device Problems
Leak / Splash	1
Total Device Problems	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Richard-Allan Scientific Company	III	Apr-04-2016

TPLC Last Update: 2019-04-02 20:57:59