Heavy Metals Control Materials

Device Code: 6019

Product Code(s): DIE

Device Classification Information

• Device Type ID: 6019
• Device Name: Heavy Metals Control Materials
• Regulation Description: Clinical Toxicology Control Material.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 862.3280 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DIE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 6019
• Device: Heavy Metals Control Materials
• Product Code: DIE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Clinical Toxicology Control Material.
• CFR Regulation Number: 862.3280 [🔎]

TPLC Last Update: 2019-04-02 21:16:08