CELLTRAK-B— 510(k) K834585

Substantially Equivalent

R&D Systems, Inc.

FDA 510(k) clearance K834585 for CELLTRAK-B, Substantially Equivalent on 1984-05-02. Applicant: R&D Systems, Inc..

Clearance details

Applicant: R&D Systems, Inc.
Product code: Code FRZ
Advisory panel: General Hospital
Date received: 1983-12-29
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FRZ

product code FRZ

Other: 1
Total: 1

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.