CLOSTRIDIUM DIFFICILE MEDIA— 510(k) K831220

Name: FDA 510(k) clearance K831220
Creator: U.S. Food and Drug Administration
Published: 1983-05-09

Substantially Equivalent

Gibco Laboratories Life Technologies, Inc.

FDA 510(k) clearance K831220 for CLOSTRIDIUM DIFFICILE MEDIA, Substantially Equivalent on 1983-05-09. Applicant: Gibco Laboratories Life Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Gibco Laboratories Life Technologies, Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1983-04-15
Decision date: 1983-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K881544 — LITTMAN AGAR1988-04-18

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K870134 — MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE1987-02-04
K864755 — PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM1987-01-05
K864014 — LOMBARD DOWELL AGAR BASE1986-10-29

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.