K935606

Substantially Equivalent

SERUM AMMONIA CONTROL

Applicant: P.T. Meditrol
Product code: JJX
Advisory panel: Clinical Chemistry
Date received: 1993-11-19
Decision date: 1994-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indonesia, ID

Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.