ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)— 510(k) K875263

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K875263 for ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R), Substantially Equivalent on 1988-02-08. Applicant: Technicon Instruments Corp..

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1987-12-22
Decision date: 1988-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.