510(k) Report

FDA applicant

Isolab, Inc.

Akron, OH44 decisions1977–199610 recalls

FDA records 44 decisions for Isolab, Inc. (Akron, OH) from 1977 to 1996: 44 510(k) clearances. Most are in product codes LCP (Assay, Glycosylated Hemoglobin) and JCM (Control, Hemoglobin, Abnormal). 10 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Isolab, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Isolab, 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?

  • LCPAssay, Glycosylated Hemoglobin7decisions
  • JCMControl, Hemoglobin, Abnormal4decisions
  • GHMTest, Sickle Cell4decisions
  • DFTIgm, Antigen, Antiserum, Control2decisions
  • JBDSystem, Analysis, Electrophoretic Hemoglobin2decisions
  • LGLAssay, Bart'S, Hemoglobin2decisions

Also: CIN (1), JPC (1), KHO (1), JJX (1), GKA (1), MLL (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K840011Resolve-HBIsolab, Inc. · 19841cites it
  • K950803Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 SampleIsolab, Inc. · 19951cites it

What has FDA decided for it lately?

  • K951014Isolab's T4 Test KitIsolab, Inc. · 1996
  • K950481Neonatal Chemistry System, Galactose Test KitIsolab, Inc. · 19965 recalls
  • K943547Phenylalanine Test KitIsolab, Inc. · 1996
  • K950803Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 SampleIsolab, Inc. · 19952 recalls
  • K950415Fluoroscan NeonatalIsolab, Inc. · 1995
  • K942276Quik-Sep Quantitative Hemoglobin S AssayIsolab, Inc. · 1995
  • K942222Quik-Sep Quantitive Hemoglobin S ControlsIsolab, Inc. · 1995
  • K944185IsoscanIsolab, Inc. · 1994

All 44 as Isolab, Inc. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K840011RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and…Sep 14, 2004
  • K840011RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.Jun 29, 2004
  • K950481Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000Jan 9, 2004
  • K950481Neonatal Total Galactose Test Kit, contents for 960 assays, Item #NG-1000Jan 9, 2004
  • K950803Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life…Jun 27, 2003
  • K950481Neonatal Total Galactose Test Kit, Item #NG-1000E, Filter #2992, contents for 960 assays.May 30, 2003