510(k) Report

510(k) · Cleared

Cleared

ON*Site Alcohol

K923337510(k) TraditionalCleared Jan 12, 1993208-day reviewClass II21 CFR 862.3040

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

Toxi-Lab, Inc. · DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

Cleared on Jan 12, 1993 after a 208-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jan 12, 1993
Review
208 days
Class
Class II
Product code
DML
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 K923337Source: 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 DML devices

DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DML

FDA has decided no DML device since 2007.

Median 510(k) review, days · DML

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

Recalls per year · DML

No recall names DML since 2007.

Adverse event reports per year · DML

2in 2024

2011: 22018: 12020: 12021: 12022: 12023: 22024: 2
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code DML, 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—02
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—01
20190—00
20200—01
20210—01
20220—01
20230—02
20240—02
20250—00
20260—0—

More from Toxi-Lab, Inc.

5 FDA decisions under this applicant name. See the company

  • K932209Toxi*Lab LTD Opiate SystemToxi-Lab, Inc. · 1993
  • K903223ON-Site AlcoholToxi-Lab, Inc. · 1991
  • K901694Spec (TM) Extraction CartridgeToxi-Lab, Inc. · 1990
  • K900626Alpha Urine SampleToxi-Lab, Inc. · 1990

Recent decisions in DML

The DML category page

  • K013538EthanolAbbott Laboratories · 2001
  • K993980Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULSyva Co. · 2000
  • K963197ON.Site AlcoholAnsys, Inc. · 1996
  • K953765Axsym Rea EthanolAbbott Laboratories · 1995
  • K952839Boehringer Mannheim Ethyl Alcohol AssayBoehringer Mannheim Corp. · 1995

https://510kreport.com/device/K923337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923337: ON*Site Alcohol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923337

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