Calibrator For Hemoglobin And Hematocrit Measurement

Device Code: 2386

Product Code(s): KRZ

Device Classification Information

• Device Type ID: 2386
• Device Name: Calibrator For Hemoglobin And Hematocrit Measurement
• Regulation Description: Calibrator For Hemoglobin Or Hematocrit Measurement.
• 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: 864.8165 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KRZ
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 7-71 CLSI H15-A3 (Replaces H15-A2)
  Reference And Selected Procedures For The Quantitative Determination Of Hemoglobin In Blood; Approved Standard - Third Edition

Total Product Life Cycle

• Device Type ID: 2386
• Device: Calibrator For Hemoglobin And Hematocrit Measurement
• Product Code: KRZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Calibrator For Hemoglobin Or Hematocrit Measurement.
• CFR Regulation Number: 864.8165 [🔎]

Device Problems
Non Reproducible Results	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:10:55