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510(k) K212849

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) by Biomérieux, Inc. — Product Code LON

K212849 is an FDA 510(k) premarket notification submitted by Biomérieux, Inc. for the device "VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)". The FDA issued a decision of Substantially Equivalent on February 4, 2022. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Biomérieux, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2022
Date Received
September 7, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
Review Panel
MI
Submission Type

Other clearances by Biomérieux, Inc.

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)
  • K232395 — ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (October 5, 2023)
  • K210793 — VIDAS NEPHROCHECK (July 8, 2022)
  • K200512 — ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (May 7, 2020)

Other clearances for product code LON

  • K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance (April 15, 2026)
  • K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (March 26, 2026)
  • K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) (August 21, 2025)
  • K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) (August 8, 2025)
  • K250447 — BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 1 (May 19, 2025)
  • K234012 — VITEK COMPACT PRO (March 14, 2025)
  • K250344 — BD Phoenix™ Automated Microbiology System (March 6, 2025)
  • K233986 — BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) (March 15, 2024)
  • K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) (March 11, 2024)
  • K232756 — Colibrí (December 27, 2023)

FDA data resources