VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)— 510(k) K202396
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K202396 for VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL), Substantially Equivalent on 2021-09-14. Applicant: bioMerieux, Inc.. Device class: 2.
Clearance details
- Applicant
- bioMerieux, 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
- Traditional
- Location
- Hazelwood, MO, US
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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.