DIALET LANCING DEVICE— 510(k) K861265

Name: FDA 510(k) clearance K861265
Creator: U.S. Food and Drug Administration
Published: 1986-04-30

Substantially Equivalent

Home Diagnostics, Inc.

FDA 510(k) clearance K861265 for DIALET LANCING DEVICE, Substantially Equivalent on 1986-04-30. Applicant: Home Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Home Diagnostics, Inc.
Product code: Code FMK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 1986-04-04
Decision date: 1986-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMK

product code FMK

Injury: 133
Malfunction: 1,278
Other: 1
Total: 1,412

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.