THIOGLYCOLLATE ENRICHED— 510(k) K820563

Name: FDA 510(k) clearance K820563
Creator: U.S. Food and Drug Administration
Published: 1982-03-16

Substantially Equivalent

American Laboratory Supply, Inc.

FDA 510(k) clearance K820563 for THIOGLYCOLLATE ENRICHED, Substantially Equivalent on 1982-03-16. Applicant: American Laboratory Supply, Inc.. Device class: 1.

Clearance details

Applicant: American Laboratory Supply, Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1982-03-02
Decision date: 1982-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KZI

product code KZI

Malfunction: 2,834
Total: 2,834

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.