Fluorescent Immunoassay, Tobramycin

Device Code: 6199

Product Code(s): LCR

Device Classification Information

• Device Type ID: 6199
• Device Name: Fluorescent Immunoassay, Tobramycin
• Regulation Description: Tobramycin 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: 862.3900 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LCR
• 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: 6199
• Device: Fluorescent Immunoassay, Tobramycin
• Product Code: LCR
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Tobramycin Test System.
• CFR Regulation Number: 862.3900 [🔎]

Device Problems
Low Test Results	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 21:18:41