Product Classification

• Device: culture media, antimicrobial susceptibility test
• Regulation Description: Culture medium for antimicrobial susceptibility tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Product Code: LKA
• Submission Type: 510(k)
• Regulation Number: 866.1700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• CLSI M43-A Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline
• CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline - Second Edition

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.