510(k) Report

510(k) · Cleared

Cleared

Allo-Type Human Immunoglobulin-

K841114510(k) TraditionalCleared Jun 14, 198491-day reviewClass I21 CFR 866.5065

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

Genetic Testing Institute · DGX Ng1m (A), Antigen, Antiserum, Control

Cleared on Jun 14, 1984 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 14, 1984
Review
91 days
Class
Class I
Product code
DGX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K841114Source: 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 DGX? 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 DGX devices

DGX Ng1m (A), Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DGX

FDA has decided no DGX device since 2007.

Median 510(k) review, days · DGX

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

Recalls per year · DGX

No recall names DGX since 2007.

Adverse event reports per year · DGX

No MAUDE report names DGX 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 Genetic Testing Institute

6 FDA decisions under this applicant name. See the company

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  • K071781PF4 IGGGenetic Testing Institute · 2007
  • K053559PF4 Enhanced Solid Phase ElisaGenetic Testing Institute · 20062 recalls
  • K993553Gti-Fviii Inhibitor AssayGenetic Testing Institute · 2000
  • K983379Gti-PF4 ElisaGenetic Testing Institute · 1999

https://510kreport.com/device/K841114 · printed Nov 6, 2026

Cite this page

510(k) Report. “K841114: Allo-Type Human Immunoglobulin-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841114

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