Refractometer For Clinical Use

Device Code: 574

Product Code(s): JRE

Device Classification Information

• Device Type ID: 574
• Device Name: Refractometer For Clinical Use
• Regulation Description: Refractometer For Clinical 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) Exempt
• CFR Regulation Number: 862.2800 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JRE
• 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: 574
• Device: Refractometer For Clinical Use
• Product Code: JRE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Refractometer For Clinical Use.
• CFR Regulation Number: 862.2800 [🔎]

Device Problems
Analyzer	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:36:43