CHROMID CARBA agar (CARB)— 510(k) K181092

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K181092 for CHROMID CARBA agar (CARB), Substantially Equivalent on 2018-07-06. Applicant: Biomerieux S.A..

Clearance details

Applicant: Biomerieux S.A.
Product code: Code JSO
Advisory panel: Microbiology
Date received: 2018-04-25
Decision date: 2018-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy-L'Etoile, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.