ANTIGENZ CHLAMYDIA— 510(k) K905402

Substantially Equivalent

Northumbria Biologicals , Ltd.

FDA 510(k) clearance K905402 for ANTIGENZ CHLAMYDIA, Substantially Equivalent on 1991-03-11. Applicant: Northumbria Biologicals , Ltd..

Clearance details

Applicant: Northumbria Biologicals , Ltd.
Product code: Code GZB
Advisory panel: Neurology
Date received: 1990-12-03
Decision date: 1991-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cramlington, GB

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Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.