510(k) Report

510(k) · Cleared

Cleared

Coat-a-Count Digitoxin Ria Kit

K812129510(k) TraditionalCleared Aug 13, 198117-day reviewClass II21 CFR 862.3300

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

Diagnostic Products Corp. · DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.

Cleared on Aug 13, 1981 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 13, 1981
Review
17 days
Class
Class II
Product code
DPG
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K812129Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All DPG devices

DPG Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPG

FDA has decided no DPG device since 2007.

Median 510(k) review, days · DPG

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

Recalls per year · DPG

No recall names DPG since 2007.

Adverse event reports per year · DPG

No MAUDE report names DPG since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
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 DPG

The DPG category page

  • K935229Opus DigitoxinPb Diagnostic Systems, Inc. · 1993
  • K780075Rialyze DigoxinMiles Laboratories, Inc. · 1978

https://510kreport.com/device/K812129 · printed Nov 4, 2026

Cite this page

510(k) Report. “K812129: Coat-a-Count Digitoxin Ria Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K812129

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026