510(k) Report

510(k) · Cleared

Cleared

Immulik Stain Plate

K812497510(k) TraditionalCleared Sep 23, 198123-day reviewClass I21 CFR 864.3010

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

Immulok, Inc. · IEG Table, Slide Warming

Cleared on Sep 23, 1981 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 23, 1981
Review
23 days
Class
Class I
Product code
IEG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K812497Source: 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 IEG devices

IEG Table, Slide Warming: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IEG

FDA has decided no IEG device since 2007.

Median 510(k) review, days · IEG

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

Recalls per year · IEG

No recall names IEG since 2007.

Adverse event reports per year · IEG

No MAUDE report names IEG 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 Immulok, Inc.

15 FDA decisions under this applicant name. See the company

  • K830971Herpes Simplex Virus Typing ReagentsImmulok, Inc. · 1983
  • K830342Culuture Set Chlamydia Isolation andImmulok, Inc. · 1983
  • K830250CVT Viral TransportsImmulok, Inc. · 1983
  • K823304Riaset Prolactin Ria KitImmulok, Inc. · 1982
  • K822785Fluoroset Immunofluorescent AntibodyImmulok, Inc. · 1982

https://510kreport.com/device/K812497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K812497: Immulik Stain Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812497

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