VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)— 510(k) K260283
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K260283 for VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL), Substantially Equivalent on 2026-10-01. Applicant: bioMerieux, Inc.. Device class: 2.
Summary
This bioMerieux clearance is for VITEK 2 AST-Streptococcus Meropenem, an antimicrobial susceptibility test for Streptococcus with meropenem. The name includes a concentration range of 0.06 to 4 µg/mL. Product code LON is automated, short-incubation antimicrobial susceptibility test systems.
Class II, 21 CFR 866.1645. The Microbiology panel reviewed it as a Traditional 510(k).
bioMerieux filed from Hazelwood, Missouri. Review took 245 days (January 29 to October 1, 2026).
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Product code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code LON
view all- K260619 — VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)
- K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
- K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
More clearances from bioMerieux, Inc.
view allAdverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.