SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED)— 510(k) K894804

Substantially Equivalent

Lifescan, Inc.

FDA 510(k) clearance K894804 for SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED), Substantially Equivalent on 1989-09-28. Applicant: Lifescan, Inc..

Clearance details

Applicant: Lifescan, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1989-07-28
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.