ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL— 510(k) K855225

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K855225 for ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL, Substantially Equivalent on 1986-01-17. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1985-12-30
Decision date: 1986-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.