2,4-dinitrofluorobenzene (spectroscopic), Nitrogen (amino-nitrogen)

Device Code: 523

Product Code(s): JMW

Device Classification Information

• Device Type ID: 523
• Device Name: 2,4-dinitrofluorobenzene (spectroscopic), Nitrogen (amino-nitrogen)
• Regulation Description: Nitrogen (amino-nitrogen) Test System.
• 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: 862.1515 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JMW
• 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: 523
• Device: 2,4-dinitrofluorobenzene (spectroscopic), Nitrogen (amino-nitrogen)
• Product Code: JMW
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Nitrogen (amino-nitrogen) Test System.
• CFR Regulation Number: 862.1515 [🔎]

TPLC Last Update: 2019-04-02 19:35:58