Enzyme Immunoassay, Phenobarbital

Device Code: 6084

Product Code(s): DLZ

Device Classification Information

• Device Type ID: 6084
• Device Name: Enzyme Immunoassay, Phenobarbital
• Regulation Description: Phenobarbital 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: 862.3660 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DLZ
• 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

Total Product Life Cycle

• Device Type ID: 6084
• Device: Enzyme Immunoassay, Phenobarbital
• Product Code: DLZ
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Phenobarbital Test System.
• CFR Regulation Number: 862.3660 [🔎]

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

TPLC Last Update: 2019-04-02 21:17:03