Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

Device Code: 6168

Product Code(s): KZT

Device Classification Information

• Device Type ID: 6168
• Device Name: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
• Regulation Description: Gentamicin 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: 862.3450 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KZT
• 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: 6168
• Device: Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin
• Product Code: KZT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Gentamicin Test System.
• CFR Regulation Number: 862.3450 [🔎]

TPLC Last Update: 2019-04-02 21:18:12