DIAMATIC, AUTOMATIC INSULIN INJECTOR— 510(k) K860284

Substantially Equivalent

Ulster Scientific, Inc.

FDA 510(k) clearance K860284 for DIAMATIC, AUTOMATIC INSULIN INJECTOR, Substantially Equivalent on 1986-04-07. Applicant: Ulster Scientific, Inc..

Clearance details

Applicant: Ulster Scientific, Inc.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 1986-01-28
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Highland, NY, US

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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.