510(k) Report

510(k) · Cleared

Cleared

Elvi Total Proteins

K792416510(k) TraditionalCleared Dec 7, 197911-day reviewClass II21 CFR 862.1440

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

Volu Sol Medical Industries · CER 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase

Cleared on Dec 7, 1979 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 7, 1979
Review
11 days
Class
Class II
Product code
CER
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K792416Source: 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 CER devices

CER 2,4-Dinitrophenylhydrazine, Lactate Dehydrogenase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CER

FDA has decided no CER device since 2007.

Median 510(k) review, days · CER

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

Recalls per year · CER

No recall names CER since 2007.

Adverse event reports per year · CER

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code CER, not matched to any one device; reports are not rates.

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—01
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 Volu Sol Medical Industries

66 FDA decisions under this applicant name. See the company

  • K822128Volu-Sol Single Differential StainVolu Sol Medical Industries · 1982
  • K822127Volu-Sol Zenkers FixativeVolu Sol Medical Industries · 1982
  • K822129Volu-Sol Bovins FixativeVolu Sol Medical Industries · 1982
  • K822126Volu-Sol Carnoy FluidVolu Sol Medical Industries · 1982
  • K822037Volu-Sol Tap Water SubstituteVolu Sol Medical Industries · 1982

https://510kreport.com/device/K792416 · printed Nov 6, 2026

Cite this page

510(k) Report. “K792416: Elvi Total Proteins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792416

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