MODIFIED FREE T4 RADIOIMMUNOASSAY KIT— 510(k) K884753

Substantially Equivalent

Advanced Magnetics, Inc.

FDA 510(k) clearance K884753 for MODIFIED FREE T4 RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1989-02-27. Applicant: Advanced Magnetics, Inc..

Clearance details

Applicant: Advanced Magnetics, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1988-11-14
Decision date: 1989-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.