System, Automated Platelet Aggregation

Device Code: 2361

Product Code(s): JOZ

Device Classification Information

• Device Type ID: 2361
• Device Name: System, Automated Platelet Aggregation
• Regulation Description: Automated Platelet Aggregation System.
• 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: 864.5700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JOZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 7-101 CLSI H51-A
  Assays Of VonWillebrand Factor Antigen And Ristocetin Cofactor Activity; Approved Guideline.

Total Product Life Cycle

• Device Type ID: 2361
• Device: System, Automated Platelet Aggregation
• Product Code: JOZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Automated Platelet Aggregation System.
• CFR Regulation Number: 864.5700 [🔎]

Premarket Reviews
Manufacturer	Decision
ACCRIVA DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
AGGREDYNE, INC.
	SUBSTANTIALLY EQUIVALENT	2
CHRONO-LOG CORP.
	SUBSTANTIALLY EQUIVALENT	1
CORAMED TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
High Test Results	23
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	26

Recalls
Manufacturer		Recall Class	Date Posted
1	Accumetrics Inc	II	Mar-11-2014

TPLC Last Update: 2019-04-02 20:10:26