Counter, Urine Particle

Device Code: 2417

Product Code(s): LKM

Device Classification Information

• Device Type ID: 2417
• Device Name: Counter, Urine Particle
• Regulation Description: Automated Cell Counter.
• 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: 864.5200 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LKM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-210 CLSI H26-A2
  Validation, Verification, And Quality Assurance Of Automated Hematology Analyzers; Proposed Standard - Second Edition

Total Product Life Cycle

• Device Type ID: 2417
• Device: Counter, Urine Particle
• Product Code: LKM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Cell Counter.
• CFR Regulation Number: 864.5200 [🔎]

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

Device Problems
Adverse Event Without Identified Device Or Use Problem	2
Improper Device Output	1
Device Emits Odor	1
Device Handling Problem	1
Incorrect Or Inadequate Test Results	1
Total Device Problems	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Sysmex America, Inc.	II	Feb-10-2014

TPLC Last Update: 2019-04-02 20:11:35