510(k) Report

510(k) · Cleared

Cleared

Ethyl Alcohol Calibrators & Control

K924733510(k) TraditionalCleared Dec 9, 199278-day reviewClass II21 CFR 862.3200

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

Diagnostic Reagents, Inc. · DNN Calibrators, Ethyl Alcohol

Cleared on Dec 9, 1992 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 9, 1992
Review
78 days
Class
Class II
Product code
DNN
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K924733Source: 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 lists a 510(k) statement for it but has not posted the file, 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 DNN devices

DNN Calibrators, Ethyl Alcohol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DNN

FDA has decided no DNN device since 2007.

Median 510(k) review, days · DNN

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

Recalls per year · DNN

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DNN

No MAUDE report names DNN since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20090—00
20100—10
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 Diagnostic Reagents, Inc.

66 FDA decisions under this applicant name. See the company

  • K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983323Digoxin ImmunoassayDiagnostic Reagents, Inc. · 1998
  • K983280Vancomycin Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998

Recent decisions in DNN

The DNN category page

  • K990516Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 19993 recalls
  • K973054Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 1997
  • K882117Ethyl Alcohol StandardVerichem Laboratories, Inc. · 19883 recalls
  • K853532Alcohol CalibratorsDiagnostic Systems · 1985
  • K810466Ethyl Alcohol Serum CalibratorSyva Co. · 1981

https://510kreport.com/device/K924733 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924733: Ethyl Alcohol Calibrators & Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924733

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