DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT— 510(k) K060510

Substantially Equivalent

Drew Scientific , Ltd.

FDA 510(k) clearance K060510 for DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT, Substantially Equivalent on 2006-06-19. Applicant: Drew Scientific , Ltd..

Clearance details

Applicant: Drew Scientific , Ltd.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2006-02-27
Decision date: 2006-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrow In Furness Cumbria, GB

Download summary PDF View on FDA.gov ↗

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.