Product Classification

• Device: system, hemoglobin, automated
• Regulation Description: Automated hemoglobin system.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: GKR
• Submission Type: 510(k)
• Regulation Number: 864.5620
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• CLSI H15-A3 Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.