SERUM AMMONIA CONTROL— 510(k) K935606

Substantially Equivalent

P.T. Meditrol

FDA 510(k) clearance K935606 for SERUM AMMONIA CONTROL, Substantially Equivalent on 1994-03-22. Applicant: P.T. Meditrol.

Clearance details

Applicant: P.T. Meditrol
Product code: 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

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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.