AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT— 510(k) K885195

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K885195 for AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT, Substantially Equivalent on 1989-02-08. Applicant: Amersham Corp..

Clearance details

Applicant: Amersham Corp.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1988-12-16
Decision date: 1989-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.