COLUMBIA 5% BLOOD AGAR— 510(k) K854228

Name: FDA 510(k) clearance K854228
Creator: U.S. Food and Drug Administration
Published: 1985-10-31

Substantially Equivalent

R. Kent Richards, Inc.

FDA 510(k) clearance K854228 for COLUMBIA 5% BLOOD AGAR, Substantially Equivalent on 1985-10-31. Applicant: R. Kent Richards, Inc.. Device class: 1.

Clearance details

Applicant: R. Kent Richards, Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1985-10-18
Decision date: 1985-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pl. Grove, UT, US

Download summary PDF View on FDA.gov ↗

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K871065 — CHLAMYDIA & VIRAL TRANSPORT MEDIUM1987-04-14
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K854450 — BILE ESCULIN AZIDE AGAR1985-11-18
K854451 — MUELLER HINTON MEDIUM1985-11-18
K854452 — MANNITOL SALT AGAR1985-11-18

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.