ABBOTT ARCHITECT TOTAL T3— 510(k) K983434

Name: FDA 510(k) clearance K983434
Creator: U.S. Food and Drug Administration
Published: 1998-11-20

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983434 for ABBOTT ARCHITECT TOTAL T3, Substantially Equivalent on 1998-11-20. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1998-09-29
Decision date: 1998-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-10051999-06-02
K991252 — AIA-PACK FT3 ASSAY1999-05-11
K981824 — OPTICOAT T3 EIA KIT1998-12-22

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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.