510(k) Report

FDA applicant

Morax

Chelsea, MI12 decisions1996–20031 recall

FDA records 12 decisions for Morax (Chelsea, MI) from 1996 to 2003: 12 510(k) clearances. Most are in product codes CFF (Immunoelectrophoretic, Immunoglobulins, (G, A…) and JHO (Electrophoretic Separation, Lipoproteins). 1 recall is 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 Morax’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Morax since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Morax 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?

  • CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)3decisions
  • JHOElectrophoretic Separation, Lipoproteins2decisions
  • LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, Hdl2decisions
  • CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes1decision
  • JKMImmunochemical, Bence-Jones Protein1decision
  • CEFElectrophoretic, Protein Fractionation1decision

Also: JBD (1), LCP (1).

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K960669Hydragel IF, 6 IF, 12 IF Penta Kits/Hydragel IF, Double IF, 2 IF, & 4 IF KitsMorax · 19964cite it

What has FDA decided for it lately?

  • K033277Hydragel CSF Isofocusing KitsMorax · 2003
  • K012789Modified to LDL/HDL Chol Direct Kit-P.N. 4005, 4103,4123Morax · 2002
  • K992148Hydragel-Mini Iso-CK Kit, Hydragel Iso-CK Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-CK 15/30 KitMorax · 1999
  • K991362Hydragel Hemoglobin (E), Mini Hemoglobin (E), 7 Hemoglobin (E), 15 Hemoglobin (E), Acid (E) Hemoglobin (E)…Morax · 19991 recall
  • K990250Hydragel LDL/HDL Chol Direct Kit-P.N. 4005, Hydragel 7 LDL/HDL Chol Direct Kit-P.N. 4103, Hydragel LDL/HDL…Morax · 1999
  • K981048Hydragel 6 CSF KitMorax · 1998
  • K974854Hydragel-Mini Lipo Kit-PN 4093, Hydragel Lipo Kit-PN 4007, Hydragel Lipo Maxi Kit-PN 4207Morax · 1998
  • K972591Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitMorax · 1998

All 12 as Morax →

What has been recalled?

1 recall linked to its devices; the latest:

  • K991362HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique…Aug 29, 2006