LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)— 510(k) K884208

Name: FDA 510(k) clearance K884208
Creator: U.S. Food and Drug Administration
Published: 1988-10-25

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K884208 for LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION), Substantially Equivalent on 1988-10-25. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1988-10-06
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZI

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K881995 — DIAMOND'S MEDIUM MODIFIED1988-06-02
K880122 — MIDDLEBROOK 7H9 BROTH1988-03-31
K880131 — LOWENSTEIN-JENSEN, GRUFT1988-03-31
K880134 — MIDDLEBROOK 7H11 AGAR1988-03-31
K880109 — CYSTINE TRYPTIC MEDIUM BASE1988-03-30

More clearances from Oxoid U.S.A., Inc.

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K891593 — LISTERIA SELECTIVE ENRICHMENT MEDIUM1989-06-09
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K874303 — STAPHYLASE TEST1987-11-06
K872956 — SORBITOL MACCONKEY AGAR NO. 3 CM 8131987-08-10
K872135 — MCBRIDE MEDIUM CM 8191987-06-15

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.