510(k) Report

510(k) · Cleared

Cleared

(125 I) Digitoxin Ria Kit

K780766510(k) TraditionalCleared Jul 27, 197883-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. · LCW Radioimmunoassay, Digitoxin (125-I)

Cleared on Jul 27, 1978 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 27, 1978
Review
83 days
Class
Class II
Product code
LCW
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780766Source: 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 LCW devices

LCW Radioimmunoassay, Digitoxin (125-I): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCW

FDA has decided no LCW device since 2007.

Median 510(k) review, days · LCW

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

Recalls per year · LCW

No recall names LCW since 2007.

Adverse event reports per year · LCW

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2025

MAUDE reports naming product code LCW, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—01
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 LCW

The LCW category page

  • K834080Matched Component Set for DigitoxinCambridge Medical Technology · 1984
  • K802461Endab Digitoxin Enzyme Immunoassay KitImmunotech Corp. · 1980

https://510kreport.com/device/K780766 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780766: (125 I) Digitoxin Ria Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780766

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