DORN BLOOD CULTURE COLLECTION TUBE— 510(k) K791303

Substantially Equivalent

Wadley Institutes of Molecular Medici

FDA 510(k) clearance K791303 for DORN BLOOD CULTURE COLLECTION TUBE, Substantially Equivalent on 1979-09-17. Applicant: Wadley Institutes of Molecular Medici.

Clearance details

Applicant: Wadley Institutes of Molecular Medici
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1979-07-16
Decision date: 1979-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.