510(k) Report

FDA applicant

Emd Chemicals, Inc.

Mchenry, IL62 decisions1982–20043 recalls

FDA records 62 decisions for Emd Chemicals, Inc. (Mchenry, IL) from 1982 to 2004: 62 510(k) clearances. Most are in product codes CHH (Enzymatic Esterase--Oxidase, Cholesterol) and CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). 3 recalls are linked to its devices.

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

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Emd Chemicals, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Emd Chemicals, Inc. since 2007.

Recalls per year

1in 2008

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

Class I Class II/III not classified

FIG. 1 — Emd Chemicals, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • CHHEnzymatic Esterase--Oxidase, Cholesterol5decisions
  • CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen4decisions
  • JISCalibrator, Primary4decisions
  • CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes3decisions
  • JQBKinetic Method, Gamma-Glutamyl Transpeptidase3decisions
  • CFRHexokinase, Glucose3decisions

Also: JIT (3), LFR (3), DNN (2), CDO (2), IAF (2), CEK (2).

What has FDA decided for it lately?

  • K031367Duopath Verotoxins Glisa TestEmd Chemicals, Inc. · 2004
  • K990516Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 19993 recalls
  • K981926Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 1998
  • K973054Ethyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. · 1997
  • K951494Amylase Test Item 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc. · 1995
  • K951750Glucose Test Item Number 97375/94Emd Chemicals, Inc. · 1995
  • K950234Total Protein Test (Tpro) Item Number: Xxxxx/R1. R2Emd Chemicals, Inc. · 1995
  • K950128Total Protein Test (Tpro) Item Xxxxx/R1. R2Emd Chemicals, Inc. · 1995

All 62 as Emd Chemicals, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K990516EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10…Mar 27, 2008
  • K990516Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule…Dec 13, 2002
  • K990516Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule…Dec 13, 2002