Calibrator For Red-cell And White-cell Counting

Device Code: 2387

Product Code(s): KSA

Device Classification Information

• Device Type ID: 2387
• Device Name: Calibrator For Red-cell And White-cell Counting
• Regulation Description: Calibrator For Red Cell And White Cell Counting.
• 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: 864.8185 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KSA
• 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: 2387
• Device: Calibrator For Red-cell And White-cell Counting
• Product Code: KSA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Calibrator For Red Cell And White Cell Counting.
• CFR Regulation Number: 864.8185 [🔎]

TPLC Last Update: 2019-04-02 20:10:56