510(k) · Cleared

Cleared

Ciba Corning Acs Free T3 Immunoassay

K932747510(k) TraditionalCleared Dec 3, 1993178-day reviewClass II21 CFR 862.1710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ciba Corning Diagnostics Corp. · CDP Radioimmunoassay, Total Triiodothyronine

Cleared on Dec 3, 1993 after a 178-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Dec 3, 1993
Review: 178 days
Class: Class II
Product code: CDP
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK932747 Ciba Corning Acs Free T3 ImmunoassayCiba Corning Diagnostics Corp. · 1993
Descendant · cites it directly · 0 of its ownK974634 Immulite Free T3Diagnostic Products Corp. · 1998 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K974634Immulite Free T3Diagnostic Products Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K932747	Ciba Corning Acs Free T3 Immunoassay	Ciba Corning Diagnostics Corp.	1993	—
+1	K974634	Immulite Free T3	Diagnostic Products Corp.	1998	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K932747, 1993–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974634	Immulite Free T3	Diagnostic Products Corp.	1998	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K974634 (Diagnostic Products Corp., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CDP devices

CDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDP

FDA has decided no CDP device since 2007.

Median 510(k) review, days · CDP

Too few CDP 510(k)s in any year since 2007 to give a median.

Recalls per year · CDP

3in 2018

2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CDP

25in 2025

2007high 365 (2018) · low 0 (2007)2025

MAUDE reports naming product code CDP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	3
2011	—	0	8
2012	—	0	2
2013	—	2	10
2014	—	1	111
2015	—	1	158
2016	—	0	150
2017	—	1	151
2018	—	3	365
2019	—	0	343
2020	—	0	209
2021	—	0	120
2022	—	0	123
2023	—	0	131
2024	—	0	41
2025	—	0	25
2026	—	0	—

https://510kreport.com/device/K932747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932747: Ciba Corning Acs Free T3 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932747

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026