ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER— 510(k) K982250

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K982250 for ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, Substantially Equivalent on 1998-07-14. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1998-06-26
Decision date: 1998-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.