BACTEC MGIT 960 PZA KIT— 510(k) K021582

Substantially Equivalent

Becton, Dickinson & CO

FDA 510(k) clearance K021582 for BACTEC MGIT 960 PZA KIT, Substantially Equivalent on 2002-07-13. Applicant: Becton, Dickinson & CO.

Clearance details

Applicant: Becton, Dickinson & CO
Product code: Code MJA
Advisory panel: Microbiology
Date received: 2002-05-14
Decision date: 2002-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparks, MD, US

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Adverse events under product code MJA

product code MJA

Malfunction: 827
Total: 827

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.