Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

Device Code: 6095

Product Code(s): DMT

Device Classification Information

• Device Type ID: 6095
• Device Name: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
• Regulation Description: Alcohol Test System.
• Regulation Medical Specialty: Toxicology
• Review Panel: Toxicology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 862.3040 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DMT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 7-48 CLSI C60-A
  Blood Alcohol Testing In The Clinical Laboratory; Approved Guideline

Total Product Life Cycle

• Device Type ID: 6095
• Device: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
• Product Code: DMT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Alcohol Test System.
• CFR Regulation Number: 862.3040 [🔎]

TPLC Last Update: 2019-04-02 21:17:13