510(k) Report

510(k) · Cleared

Cleared

Virgo (R) Microwell Alt Assay

K884784510(k) TraditionalCleared Dec 29, 198844-day reviewClass I21 CFR 862.1030

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

Electro-Nucleonics, Inc. · CKD Hydrazone Colorimetry, Alt/Sgpt

Cleared on Dec 29, 1988 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 29, 1988
Review
44 days
Class
Class I
Product code
CKD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K884784Source: 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 CKD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 CKD devices

CKD Hydrazone Colorimetry, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKD

FDA has decided no CKD device since 2007.

Median 510(k) review, days · CKD

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

Recalls per year · CKD

No recall names CKD since 2007.

Adverse event reports per year · CKD

No MAUDE report names CKD 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 Electro-Nucleonics, Inc.

9 FDA decisions under this applicant name. See the company

  • K893718Deltatest (R) Lipase IIElectro-Nucleonics, Inc. · 1989
  • K883670Serological Test Kit for Igg Anti. Epstein-Barr VIElectro-Nucleonics, Inc. · 1989
  • K883427Virgo (R) VZV-Igg ElisaElectro-Nucleonics, Inc. · 19891 recall
  • K883282Virgo HSV-1 Igg ElisaElectro-Nucleonics, Inc. · 1989
  • K883281Virgo HSV-2 Igg ElisaElectro-Nucleonics, Inc. · 1989

Recent decisions in CKD

The CKD category page

  • K991834Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772Cholestech Corp. · 19991 recall
  • K941192Ortho Alt Microwell Test SystemOrtho Diagnostic Systems, Inc. · 1995
  • K896237Cobas Ready Alt ReagentRoche Diagnostic Systems, Inc. · 1990
  • K883387Alanine Amino Transferase (Colorimetric Method)Tech-Co, Inc. · 1988
  • K864082Reflotron (R) Alt (GPT)Boehringer Mannheim Corp. · 19861 recall

https://510kreport.com/device/K884784 · printed Nov 4, 2026

Cite this page

510(k) Report. “K884784: Virgo (R) Microwell Alt Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K884784

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