BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)— 510(k) K123903

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K123903 for BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic), Substantially Equivalent on 2013-05-13. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code MDB
Advisory panel: Microbiology
Date received: 2012-12-19
Decision date: 2013-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

Download summary PDF View on FDA.gov ↗

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.