CONTACT PLATE LECITHIN & POLYSORBATE 80— 510(k) K830063

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K830063 for CONTACT PLATE LECITHIN & POLYSORBATE 80, Substantially Equivalent on 1983-02-09. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1983-01-11
Decision date: 1983-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.