Product Classification

• Device: calibrator for hemoglobin and hematocrit measurement
• Regulation Description: Calibrator for hemoglobin or hematocrit measurement.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: KRZ
• Submission Type: 510(k)
• Regulation Number: 864.8165
• 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

Guidance Document

• Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final  

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.