ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER— 510(k) K973966

Name: FDA 510(k) clearance K973966
Creator: U.S. Food and Drug Administration
Published: 1997-10-31

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K973966 for ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, Substantially Equivalent on 1997-10-31. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1997-10-17
Decision date: 1997-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDP

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K001607 — REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)2000-10-05
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

More clearances from Beckman Instruments, Inc.

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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 →

Recalls naming K973966

K-number listed on FDA's recall record

Z-2239-2020 — Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.Class II·Terminated·Beckman Coulter Inc.·20190430
Z-2635-2017 — Access Total T3, A34435H, Catalog No. 33830Class II·Terminated·Beckman Coulter Inc.·20170509
Z-2227-2012 — Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.Class III·Terminated·Beckman Coulter Inc.·20111011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973966.

Data sourced from openFDA. This site is unofficial and independent of the FDA.