K003062

Substantially Equivalent

BACTEC MGIT 960 SIR KITS

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
MJA
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sparks, MD, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MJA

product code MJA
Malfunction
827
Total
827

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.