ECG BASED MEDIA— 510(k) K873267

Name: FDA 510(k) clearance K873267
Creator: U.S. Food and Drug Administration
Published: 1987-11-04

Substantially Equivalent

Central Media

FDA 510(k) clearance K873267 for ECG BASED MEDIA, Substantially Equivalent on 1987-11-04. Applicant: Central Media. Device class: 1.

Clearance details

Applicant: Central Media
Product code: Code KZI
Device class: Class 1
Regulation: 21 CFR 866.2330
Advisory panel: Microbiology
Date received: 1987-08-11
Decision date: 1987-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZI

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K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)1988-10-25
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

More clearances from Central Media

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K873257 — GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.1987-11-06
K873258 — STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA1987-11-06
K873259 — SPECIALTY MEDIA1987-11-06
K873260 — CORYNEBACTERIA ISOLATION MEDIA1987-11-06
K873268 — MUELLER HINTON MEDIA1987-11-04

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.