System, Test, Low Density, Lipoprotein

Device Code: 618

Product Code(s): MRR

Device Classification Information

• Device Type ID: 618
• Device Name: System, Test, Low Density, Lipoprotein
• Regulation Description: Lipoprotein Test System.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.1475 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MRR
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-88 CLSI C37-A
  Preparation And Validation Of Commutable Frozen Human Serum Pools As Secondary Reference Materials For Cholesterol Measurement Procedures; Approved Guideline

Total Product Life Cycle

• Device Type ID: 618
• Device: System, Test, Low Density, Lipoprotein
• Product Code: MRR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Lipoprotein Test System.
• CFR Regulation Number: 862.1475 [🔎]

Premarket Reviews
Manufacturer	Decision
RANDOX LABORATORIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Low Test Results	4
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Ortho-Clinical Diagnostics	II	Nov-17-2018
2	Roche Diagnostics Operations, Inc.	II	Jun-27-2015
3	Siemens Healthcare Diagnostics, Inc.	II	May-11-2016

TPLC Last Update: 2019-04-02 19:37:31