DELFIA FREE THYROXINE (FT4) KIT— 510(k) K894605

Substantially Equivalent

Pharmacia, Inc.

FDA 510(k) clearance K894605 for DELFIA FREE THYROXINE (FT4) KIT, Substantially Equivalent on 1989-09-18. Applicant: Pharmacia, Inc..

Clearance details

Applicant: Pharmacia, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1989-07-20
Decision date: 1989-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piscataway, NJ, US

Download summary PDF View on FDA.gov ↗

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.