AEGIS I.V. STRIPS— 510(k) K812080

Substantially Equivalent

Warner-Lambert Co.

FDA 510(k) clearance K812080 for AEGIS I.V. STRIPS, Substantially Equivalent on 1981-08-03. Applicant: Warner-Lambert Co..

Clearance details

Applicant: Warner-Lambert Co.
Product code: Code KMK
Advisory panel: General Hospital
Date received: 1981-07-22
Decision date: 1981-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

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.