SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA)— 510(k) K950958

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K950958 for SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA), Substantially Equivalent on 1995-05-08. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1995-02-15
Decision date: 1995-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.