510(k) Report

510(k) · Cleared

Cleared

Test, Ria, Serum Digoxin

K760077510(k) TraditionalCleared Jul 16, 197628-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

Smithkline Diagnostics, Inc. · DND Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Solid Phase Sep.

Cleared on Jul 16, 1976 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 16, 1976
Review
28 days
Class
Class II
Product code
DND
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K760077Source: 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 DND devices

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

FDA decisions per year · DND

FDA has decided no DND device since 2007.

Median 510(k) review, days · DND

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

Recalls per year · DND

No recall names DND since 2007.

Adverse event reports per year · DND

No MAUDE report names DND 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 Smithkline Diagnostics, Inc.

42 FDA decisions under this applicant name. See the company

  • K961062Flexsure ObtSmithkline Diagnostics, Inc. · 1996
  • K960183Flexsure HP,Controls for Flexsurehp,Flexpack HP (Abbott Diagnostics)Andcontrols for Flexpack HP (Abbott…Smithkline Diagnostics, Inc. · 1996
  • K934863Flexsure HPSmithkline Diagnostics, Inc. · 1994
  • K880499Hemoccult Sensitive TestSmithkline Diagnostics, Inc. · 1988
  • K875131(SKD) Cholesterol Test KitSmithkline Diagnostics, Inc. · 1988

https://510kreport.com/device/K760077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K760077: Test, Ria, Serum Digoxin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K760077

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