SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)— 510(k) K171476

Substantially Equivalent

Awareness Technology, Inc.

FDA 510(k) clearance K171476 for SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-), Substantially Equivalent on 2018-02-27. Applicant: Awareness Technology, Inc..

Clearance details

Applicant: Awareness Technology, Inc.
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 2017-05-19
Decision date: 2018-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm City, FL, US

Download summary PDF View on FDA.gov ↗

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.