DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)— 510(k) K973510

Substantially Equivalent

Immuno-U.S., Inc.

FDA 510(k) clearance K973510 for DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML), Substantially Equivalent on 1997-12-08. Applicant: Immuno-U.S., Inc..

Clearance details

Applicant: Immuno-U.S., Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1997-09-16
Decision date: 1997-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.