SUPREME II CONTROL SOLUTIONS— 510(k) K983432

Substantially Equivalent

Chronimed, Inc.

FDA 510(k) clearance K983432 for SUPREME II CONTROL SOLUTIONS, Substantially Equivalent on 1998-12-17. Applicant: Chronimed, Inc..

Clearance details

Applicant: Chronimed, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1998-09-29
Decision date: 1998-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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.