Product Classification

• Device: hemoglobin for donor testing
• Regulation Description: Whole blood hemoglobin assays.
• Definition: Assays hemoglobin concentration test for blood donors.
• Physical State: Pulse oximeter.
• Technical Method: Pulse oximetry of blood samples.
• Target Area: Clinical whole blood.
• Regulation Medical Specialty: Hematology
• Review Panel: Hematology
• Product Code: QGU
• Premarket Review: Center for Biologics Evaluation & Research (CBER)
• Submission Type: 510(k)
• Regulation Number: 864.7500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible