INVISIJECT RESUSABLE AUTO-INJECTOR— 510(k) K032425

Substantially Equivalent

Biogen

FDA 510(k) clearance K032425 for INVISIJECT RESUSABLE AUTO-INJECTOR, Substantially Equivalent on 2003-11-05. Applicant: Biogen.

Clearance details

Applicant: Biogen
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2003-08-06
Decision date: 2003-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.