510(k) Report

510(k) · Cleared

Cleared

Antibody to Mumps Virus Ifa Test

K822826510(k) TraditionalCleared Dec 3, 198273-day reviewClass I21 CFR 866.3380

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

Electro-Nucleonics Laboratories, Inc. · GRA Antiserum, Fluorescent, Mumps Virus

Cleared on Dec 3, 1982 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 3, 1982
Review
73 days
Class
Class I
Product code
GRA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822826Source: 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 GRA devices

GRA Antiserum, Fluorescent, Mumps Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GRA

FDA has decided no GRA device since 2007.

Median 510(k) review, days · GRA

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

Recalls per year · GRA

No recall names GRA since 2007.

Adverse event reports per year · GRA

No MAUDE report names GRA 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 Laboratories, Inc.

41 FDA decisions under this applicant name. See the company

  • K873925Virgo (TM) Measles Igg ElisaElectro-Nucleonics Laboratories, Inc. · 1988
  • K873617Gemstar II SystemElectro-Nucleonics Laboratories, Inc. · 1987
  • K873416Multi-Access Reagent DispenserElectro-Nucleonics Laboratories, Inc. · 1987
  • K873358Gemeni Uric Acid U.V.Electro-Nucleonics Laboratories, Inc. · 1987
  • K873088Virgo (TM) Rubella Igg ElisaElectro-Nucleonics Laboratories, Inc. · 1987

Recent decisions in GRA

The GRA category page

  • K894624Mumps VirusBion Ent., Ltd. · 1989
  • K770216Viral Antisera, Fluorescein LabeledFlow Laboratories, Inc. · 1977

https://510kreport.com/device/K822826 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822826: Antibody to Mumps Virus Ifa Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822826

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