510(k) Report

510(k) · Cleared

Cleared

Total Iron Binding Capacity

K780412510(k) TraditionalCleared May 26, 197872-day reviewClass I21 CFR 862.1415

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

Diagnostic Corp. of America · JQG Radiometric, Fe59, Iron Binding Capacity

Cleared on May 26, 1978 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 26, 1978
Review
72 days
Class
Class I
Product code
JQG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780412Source: 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.

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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 JQG devices

JQG Radiometric, Fe59, Iron Binding Capacity: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQG

FDA has decided no JQG device since 2007.

Median 510(k) review, days · JQG

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

Recalls per year · JQG

No recall names JQG since 2007.

Adverse event reports per year · JQG

No MAUDE report names JQG 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 Corp. of America

3 FDA decisions under this applicant name. See the company

  • K810477Dca Digox-Syn Ria TestDiagnostic Corp. of America · 1981
  • K781150Ria TSH in Human Serum or PlasmaDiagnostic Corp. of America · 1978

Recent decisions in JQG

The JQG category page

  • K811954Combo-Fer Iron DiagnosticImmuno Assay Corp. · 1981
  • K800710Ferritiron Kit Cat. #RP-1100Ria Products, Inc. · 1980
  • K800868Ferro-Quant TM FE 59 Test KitMallinckrodt Critical Care · 1980
  • K790133Spinsep-FE59Nuclear Diagnostics, Inc. · 1979

https://510kreport.com/device/K780412 · printed Nov 3, 2026

Cite this page

510(k) Report. “K780412: Total Iron Binding Capacity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K780412

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