SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT— 510(k) K963542

Substantially Equivalent

Sigma Diagnostics, Inc.

FDA 510(k) clearance K963542 for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT, Substantially Equivalent on 1996-09-27. Applicant: Sigma Diagnostics, Inc..

Clearance details

Applicant: Sigma Diagnostics, Inc.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1996-09-04
Decision date: 1996-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.