Standards And Controls, Hemoglobin, Normal And Abnormal

Device Code: 2248

Product Code(s): GFS

Device Classification Information

• Device Type ID: 2248
• Device Name: Standards And Controls, Hemoglobin, Normal And Abnormal
• Regulation Description: Hematology Quality Control Mixture.
• 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: 864.8625 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GFS
• 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: 2248
• Device: Standards And Controls, Hemoglobin, Normal And Abnormal
• Product Code: GFS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Hematology Quality Control Mixture.
• CFR Regulation Number: 864.8625 [🔎]

TPLC Last Update: 2019-04-02 20:08:21