Mixture, Hematology Quality Control

Device Code: 2371

Product Code(s): JPK

Device Classification Information

• Device Type ID: 2371
• Device Name: Mixture, Hematology Quality Control
• Regulation Description: Hematology Quality Control Mixture.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 864.8625 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JPK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2371
• Device: Mixture, Hematology Quality Control
• Product Code: JPK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hematology Quality Control Mixture.
• CFR Regulation Number: 864.8625 [🔎]

Premarket Reviews
Manufacturer	Decision
R & D SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRECK
	SUBSTANTIALLY EQUIVALENT	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Clinical Diagnostic Solutions	II	Apr-09-2014

TPLC Last Update: 2019-04-02 20:10:36