FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)— 510(k) K962355

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K962355 for FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM), Substantially Equivalent on 1996-07-12. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1996-06-18
Decision date: 1996-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, 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.