REAGENTS & STANDARDS IL 501 NA/K— 510(k) K840557

Substantially Equivalent

Shaban Mfg. Co.

FDA 510(k) clearance K840557 for REAGENTS & STANDARDS IL 501 NA/K, Substantially Equivalent on 1984-04-04. Applicant: Shaban Mfg. Co..

Clearance details

Applicant: Shaban Mfg. Co.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1984-02-08
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.