Culture Media, Antimicrobial Susceptibility Test

Device Code: 3421

Product Code(s): LKA

Device Classification Information

• Device Type ID: 3421
• Device Name: Culture Media, Antimicrobial Susceptibility Test
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• Regulation Medical Specialty: Microbiology
• Review Panel: Microbiology
• Premarket Review: Office Of In Vitro Diagnostics And Radiological Health (OIR)
• Submission Type: 510(k)
• CFR Regulation Number: 866.1700 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LKA
• 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

• 7-236 CLSI M43-A
  Methods For Antimicrobial Susceptibility Testing For Human Mycoplasmas; Approved Guideline.
• 7-262 CLSI M45 3rd Edition
  Methods For Antimicrobial Dilution And Disk Susceptibility Testing Of Infrequently Isolated Or Fastidious Bacteria.

Total Product Life Cycle

• Device Type ID: 3421
• Device: Culture Media, Antimicrobial Susceptibility Test
• Product Code: LKA
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Culture Medium For Antimicrobial Susceptibility Tests.
• CFR Regulation Number: 866.1700 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Remel Inc	II	Mar-03-2017

TPLC Last Update: 2019-04-02 20:29:24