CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL— 510(k) K850724

Name: FDA 510(k) clearance K850724
Creator: U.S. Food and Drug Administration
Published: 1985-03-25

Substantially Equivalent

Rapid City Regional Hospital, Inc.

FDA 510(k) clearance K850724 for CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL, Substantially Equivalent on 1985-03-25. Applicant: Rapid City Regional Hospital, Inc.. Device class: 1.

Clearance details

Applicant: Rapid City Regional Hospital, Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1985-02-22
Decision date: 1985-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rapid City, SD, 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.