VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)— 510(k) K212849
Substantially EquivalentBiomérieux, Inc.
FDA 510(k) clearance K212849 for VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL), Substantially Equivalent on 2022-02-04. Applicant: Biomérieux, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomérieux, Inc.
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hazelwood, MO, US
Recent devices under product code LON
view all- 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)
- K250447 — BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)
Adverse 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.