Atomic Absorption Spectrophotometer, General Use

Device Code: 5989

Product Code(s): JXR

Device Classification Information

• Device Type ID: 5989
• Device Name: Atomic Absorption Spectrophotometer, General Use
• Regulation Description: Atomic Absorption Spectrophotometer For Clinical Use.
• Regulation Medical Specialty: Clinical Chemistry
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.2850 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: JXR
• 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: 5989
• Device: Atomic Absorption Spectrophotometer, General Use
• Product Code: JXR
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Atomic Absorption Spectrophotometer For Clinical Use.
• CFR Regulation Number: 862.2850 [🔎]

TPLC Last Update: 2019-04-02 21:15:41