OXOID SIGNAL BLOOD CULTURE SYSTEM— 510(k) K862946

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K862946 for OXOID SIGNAL BLOOD CULTURE SYSTEM, Substantially Equivalent on 1986-11-05. Applicant: Oxoid U.S.A., Inc..

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1986-08-05
Decision date: 1986-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampshire Rg 24 Op, GB

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Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.