Device, Automated Sedimentation Rate

Device Code: 2304

Product Code(s): GKB

Device Classification Information

• Device Type ID: 2304
• Device Name: Device, Automated Sedimentation Rate
• Regulation Description: Automated Sedimentation Rate Device.
• 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: 864.5800 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: GKB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 2304
• Device: Device, Automated Sedimentation Rate
• Product Code: GKB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Automated Sedimentation Rate Device.
• CFR Regulation Number: 864.5800 [🔎]

Device Problems
Incorrect, Inadequate Or Imprecise Result Or Readings	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:09:18