510(k) Report

510(k) · Cleared

Cleared

CBR-Digoxin Antiserum

K780498510(k) TraditionalCleared Apr 5, 19788-day reviewClass II21 CFR 862.3320

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

Clinical Bioresearch · DKA Antiserum, Digoxin

Cleared on Apr 5, 1978 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 5, 1978
Review
8 days
Class
Class II
Product code
DKA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780498Source: 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 DKA devices

DKA Antiserum, Digoxin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKA

FDA has decided no DKA device since 2007.

Median 510(k) review, days · DKA

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

Recalls per year · DKA

No recall names DKA since 2007.

Adverse event reports per year · DKA

No MAUDE report names DKA 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 Clinical Bioresearch

4 FDA decisions under this applicant name. See the company

  • K780707T4-Ria KitClinical Bioresearch · 1978
  • K780499CBR-T3RIA KitClinical Bioresearch · 1978
  • K780500CBR-T3 Uptake KitClinical Bioresearch · 1978

Recent decisions in DKA

The DKA category page

  • K934003Stratus Digoxin Flourometric Enzyme ImmunoassayBaxter Diagnostics, Inc. · 1994
  • K780316Rabbit Antibody to DigoxinPcl-Ria, Inc. · 1978

https://510kreport.com/device/K780498 · printed Nov 3, 2026

Cite this page

510(k) Report. “K780498: CBR-Digoxin Antiserum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K780498

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