510(k) Report

510(k) · Cleared

Cleared

Easy-Test (Che) Reagent, Item NO. 67522/93

K860641510(k) TraditionalCleared Apr 3, 198642-day reviewClass I21 CFR 862.3240

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

Em Diagnostic Systems, Inc. · DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase

Cleared on Apr 3, 1986 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 3, 1986
Review
42 days
Class
Class I
Product code
DLI
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K860641Source: 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 DLI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 DLI devices

DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DLI

FDA has decided no DLI device since 2007.

Median 510(k) review, days · DLI

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

Recalls per year · DLI

No recall names DLI since 2007.

Adverse event reports per year · DLI

No MAUDE report names DLI 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 Em Diagnostic Systems, Inc.

288 FDA decisions under this applicant name. See the company

  • K935181Aspartate Aminotransferase (Ast) TestEm Diagnostic Systems, Inc. · 1994
  • K935180Alanine Aminotransferase (Alt) TestEm Diagnostic Systems, Inc. · 1994
  • K935179Emds Albumin (Alb) TestEm Diagnostic Systems, Inc. · 1993
  • K935178Emds Phosphorous (Phos) TestEm Diagnostic Systems, Inc. · 1993
  • K935175Lactate Dehydrogenase (LD)Em Diagnostic Systems, Inc. · 1993

Recent decisions in DLI

The DLI category page

  • K950180Dupont Dimension (R) Pseudocholinesterase MethodE.I. Dupont DE Nemours & Co., Inc. · 1995
  • K930208Cholinesterase Method for Technicon CHEM1/TechnicoHeraeus Kulzer, Inc. · 1993
  • K860350Serum Cholinesterase Reagent SetSterling Diagnostics, Inc. · 1986
  • K833062Serum Cholinesterase Reagent SetSterling Biochemical, Inc. · 1983
  • K771024Cholinesterase Reagent SystemAmerican Monitor Corp. · 1977

https://510kreport.com/device/K860641 · printed Nov 3, 2026

Cite this page

510(k) Report. “K860641: Easy-Test (Che) Reagent, Item NO. 67522/93.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K860641

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