AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665— 510(k) K880039

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K880039 for AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665, Substantially Equivalent on 1988-02-24. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1988-01-05
Decision date: 1988-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.