ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870— 510(k) K851278

Substantially Equivalent

Stanbio Laboratory

FDA 510(k) clearance K851278 for ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870, Substantially Equivalent on 1985-04-17. Applicant: Stanbio Laboratory.

Clearance details

Applicant: Stanbio Laboratory
Product code: Code LDP
Advisory panel: Clinical Toxicology
Date received: 1985-04-01
Decision date: 1985-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.