510(k) Report

510(k) · Cleared

Cleared

Allergenetics Aller-Specific Ige Serum

K842969510(k) TraditionalCleared Aug 28, 198429-day reviewClass II21 CFR 866.5510

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

Allergenetics · DGP Ige, Fitc, Antigen, Antiserum, Control

Cleared on Aug 28, 1984 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 28, 1984
Review
29 days
Class
Class II
Product code
DGP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K842969Source: 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 DGP devices

DGP Ige, Fitc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DGP

FDA has decided no DGP device since 2007.

Median 510(k) review, days · DGP

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

Recalls per year · DGP

No recall names DGP since 2007.

Adverse event reports per year · DGP

No MAUDE report names DGP 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 Allergenetics

8 FDA decisions under this applicant name. See the company

  • K851512Allergenetics Ige Fast TestAllergenetics · 1985
  • K842970Allergentics Total Ige/TheophyllineAllergenetics · 1984
  • K833418Chymofast TestAllergenetics · 1984
  • K834594Total Ige Fast TestAllergenetics · 1984
  • K833419Labeled 125I Anti-IgeAllergenetics · 1984

Recent decisions in DGP

The DGP category page

  • K931224Vidas Total Ige (Ige) AssayBiomerieux Vitek, Inc. · 1993
  • K863327Immpulse Ige Assay ReagentsSclavo, Inc. · 1986
  • K842749Fiax Total Ige Test KitIntl. Diagnostic Technology · 1984

https://510kreport.com/device/K842969 · printed Nov 4, 2026

Cite this page

510(k) Report. “K842969: Allergenetics Aller-Specific Ige Serum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K842969

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