Device, Automated Cell-locating

Device Code: 2360

Product Code(s): JOY

Device Classification Information

• Device Type ID: 2360
• Device Name: Device, Automated Cell-locating
• Regulation Description: Automated Cell-locating Device.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 864.5260 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JOY
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-165 CLSI H20-A2 (Replaces H20-A)
  Reference Leukocyte (WBC) Differential Count (Proportional) And Evaluation Of Instrumental Methods; Approved Standard - Second Edition

Total Product Life Cycle

• Device Type ID: 2360
• Device: Device, Automated Cell-locating
• Product Code: JOY
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Cell-locating Device.
• CFR Regulation Number: 864.5260 [🔎]

Premarket Reviews
Manufacturer	Decision
SYSMEX
	SUBSTANTIALLY EQUIVALENT	1
SYSMEX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Display Or Visual Feedback Problem	4
Patient Data Problem	1
Total Device Problems	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Cellavision AB	II	Jun-13-2018
2	Leica Biosystems Richmond Inc.	III	Jun-20-2016
3	Roche Diagnostics Hematology	II	Jul-26-2018

TPLC Last Update: 2019-04-02 20:10:25