Automated Radioimmunoassay Systems, For Clinical Use

Device Code: 603

Product Code(s): LCI

Device Classification Information

• Device Type ID: 603
• Device Name: Automated Radioimmunoassay Systems, For Clinical Use
• Regulation Description: General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Clinical Chemistry
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.2050 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: LCI
• 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: 603
• Device: Automated Radioimmunoassay Systems, For Clinical Use
• Product Code: LCI
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: General Purpose Laboratory Equipment Labeled Or Promoted For A Specific Medical Use.
• CFR Regulation Number: 862.2050 [🔎]

TPLC Last Update: 2019-04-02 19:37:10