510(k) Report

510(k) · Cleared

Cleared

Coat-a-Count Free Thyroxine Kit/Componen

K822882510(k) TraditionalCleared Nov 5, 198245-day reviewClass II21 CFR 862.1695

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

Diagnostic Products Corp. · CEC Radioimmunoassay, Free Thyroxine

Cleared on Nov 5, 1982 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Nov 5, 1982
Review
45 days
Class
Class II
Product code
CEC
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared19801990200020102020
  1. This deviceK822882 Coat-a-Count Free Thyroxine Kit/ComponenDiagnostic Products Corp. · 1982
  2. Descendant · cites it directly · 0 of its ownK971792 Immulite Free T4 (2-Step)Diagnostic Products Corp. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K971792Immulite Free T4 (2-Step)Diagnostic Products Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K822882Coat-a-Count Free Thyroxine Kit/ComponenDiagnostic Products Corp.1982—
+1K971792Immulite Free T4 (2-Step)Diagnostic Products Corp.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K822882, 1982–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in CEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CEC device

  1. #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, 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.

NumberDeviceApplicantDecidedDescendants
K971792Immulite Free T4 (2-Step)Diagnostic Products Corp.19970

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, K971792 (Diagnostic Products Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CEC devices

CEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEC

1in 2024

2007: 12008: 22009: 12012: 12013: 22014: 32015: 12016: 12017: 12018: 22023: 12024: 1
2007high 3 (2014) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CEC

238in 2014

2014: 238 days median
2007high 238 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CEC

1in 2018

2010: 32013: 12018: 1
2007high 3 (2010) · low 0 (2007)2026

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

Adverse event reports per year · CEC

213in 2025

2009: 22010: 72011: 152012: 62013: 62014: 402015: 1662016: 1482017: 1962018: 1992019: 1672020: 1062021: 962022: 812023: 992024: 2762025: 213
2007high 276 (2024) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20082—00
20091—02
20100—37
20110—015
20121—06
20132—16
20143238040
20151—0166
20161—0148
20171—0196
20182—1199
20190—0167
20200—0106
20210—096
20220—081
20231—099
20241—0276
20250—0213
20260—0—

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in CEC

The CEC category page

  • K240273Access Free T4Beckman Coulter, Inc. · 2024
  • K220456Elecsys FT4 IVRoche Diagnostics · 2023
  • K182423Maglumi 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd. · 2018
  • K181233Elecsys FT4 IIIRoche Diagnostics · 2018
  • K173122Abbott Architect Free T4Abbott Laboratories · 20171 recall

https://510kreport.com/device/K822882 · printed Nov 4, 2026

Cite this page

510(k) Report. “K822882: Coat-a-Count Free Thyroxine Kit/Componen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K822882

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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