BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA— 510(k) K881115

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K881115 for BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA, Substantially Equivalent on 1988-03-24. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic.

Clearance details

Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code
Code JSG
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lakes, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JSG

product code JSG
Malfunction
817
Total
817

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.