K000378

Substantially Equivalent

BACT/ALERT MB CULTURE BOTTLE

Applicant: Organon Teknika Corp.
Product code: MDB
Advisory panel: Microbiology
Date received: 2000-02-07
Decision date: 2000-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Adverse events under product code MDB

product code MDB

Death: 6
Malfunction: 5,490
Total: 5,496

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.