ROCHE COBAS MICROS HEMATOLOGY ANALYZER— 510(k) K953448

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K953448 for ROCHE COBAS MICROS HEMATOLOGY ANALYZER, Substantially Equivalent on 1995-10-13. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code GKZ
Advisory panel: Hematology
Date received: 1995-07-17
Decision date: 1995-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

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Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

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.