ENRICHED CULTURE MEDIUM— 510(k) K850735

Substantially Equivalent

Roseville Medical Laboratoriesu

FDA 510(k) clearance K850735 for ENRICHED CULTURE MEDIUM, Substantially Equivalent on 1985-03-16. Applicant: Roseville Medical Laboratoriesu.

Clearance details

Applicant: Roseville Medical Laboratoriesu
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1985-02-20
Decision date: 1985-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, CA, US

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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.