ACETASITE— 510(k) K931257

Substantially Equivalent

Gds Diagnostics

FDA 510(k) clearance K931257 for ACETASITE, Substantially Equivalent on 1993-07-08. Applicant: Gds Diagnostics.

Clearance details

Applicant: Gds Diagnostics
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 1993-03-12
Decision date: 1993-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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Adverse events under product code LDP

product code LDP

Other: 1
Total: 1

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.