510(k) K855203— GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD

Substantially Equivalent

Miles Laboratories, Inc.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code FMK
Advisory panel: General, Plastic Surgery
Date received: 1985-12-26
Decision date: 1986-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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.