Cytocentrifuge

Device Code: 4966

Product Code(s): IFB

Device Classification Information

• Device Type ID: 4966
• Device Name: Cytocentrifuge
• Regulation Description: Cytocentrifuge.
• 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: 864.3300 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: IFB
• 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: 4966
• Device: Cytocentrifuge
• Product Code: IFB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Cytocentrifuge.
• CFR Regulation Number: 864.3300 [🔎]

Device Problems
Device Operates Differently Than Expected	3
Circuit Board	2
Thermal Decomposition Of Device	2
Incorrect, Inadequate Or Imprecise Result Or Readings	1
Device Emits Odor	1
Total Device Problems	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Richard-Allan Scientific Company	III	Aug-11-2018

TPLC Last Update: 2019-04-02 20:58:09