COLUMBIA AGAR W/COLISTIN, NALADIXIC— 510(k) K841139

Substantially Equivalent

Anaerobe Systems

FDA 510(k) clearance K841139 for COLUMBIA AGAR W/COLISTIN, NALADIXIC, Substantially Equivalent on 1984-03-26. Applicant: Anaerobe Systems.

Clearance details

Applicant: Anaerobe Systems
Product code: Code JSJ
Advisory panel: Microbiology
Date received: 1984-03-16
Decision date: 1984-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.