DeviceClearance

Product code JGS— Clinical Chemistry

PROLYTE ELECTROLYTE ANALYZER

Classification name
Electrode, Ion Specific, Sodium
Device class
Class 2
Regulation
21 CFR 862.1665
Advisory panel
Clinical Chemistry
Total cleared
162
First cleared
Most recent

Market context for product code JGS

FDA has cleared 162 devices under product code JGS between 1977 and 2026, filed by 80 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code JGS

Adverse events under product code JGS

product code JGS
Malfunction
535
Total
535

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code JGS

1–100 of 162

Data sourced from openFDA. This site is unofficial and independent of the FDA.