VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)— 510(k) K971449

Substantially Equivalent

Becton Dickinson Vacutainer Systems

FDA 510(k) clearance K971449 for VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE), Substantially Equivalent on 1997-06-17. Applicant: Becton Dickinson Vacutainer Systems.

Clearance details

Applicant
Becton Dickinson Vacutainer Systems
Product code
Code GIM
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Franklin Lake, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GIM

product code GIM
Malfunction
1,325
Total
1,325

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.