CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ— 510(k) K850832

Name: FDA 510(k) clearance K850832
Creator: U.S. Food and Drug Administration
Published: 1985-03-29

Substantially Equivalent

Oxoid U.S.A., Inc.

FDA 510(k) clearance K850832 for CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ, Substantially Equivalent on 1985-03-29. Applicant: Oxoid U.S.A., Inc.. Device class: 1.

Clearance details

Applicant: Oxoid U.S.A., Inc.
Product code: Code JSJ
Device class: Class 1
Regulation: 21 CFR 866.2360
Advisory panel: Microbiology
Date received: 1985-02-15
Decision date: 1985-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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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.