Isolab, Inc.
Medical device manufacturer in Akron, OH.
44510(k) clearances
0PMA approvals
0recalls
Device types
- LCP Assay, Glycosylated Hemoglobin 7
- JCM Control, Hemoglobin, Abnormal 4
- GHM Test, Sickle Cell 4
- JBD System, Analysis, Electrophoretic Hemoglobin 2
- LGL Assay, Bart'S, Hemoglobin 2
- DFT Igm, Antigen, Antiserum, Control 2
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- MLL Hemoglobin C (Abnormal Hemoglobin Variant) 1
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- GGM Control, Hemoglobin 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- JHF Colorimetric Method, Lecithin/Sphingomyelin… 1
- LJC Enzyme Linked Immunoabsorbent Assay… 1
- GQO Antisera, Cf, Herpesvirus Hominis 1,2 1
- DFI Total Spinal-Fluid, Antigen, Antiserum… 1
- GKA Abnormal Hemoglobin Quantitation 1
- JPC Hemoglobin F Quantitation 1
- JJX Single (Specified) Analyte Controls… 1
- JPD Hemoglobin A2 Quantitation 1
- KQI Assay, Fetal Hemoglobin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
| K931234 | Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional | 05/11/1993SE |
| K930070 | Hemocard Hemoglobin ECKA · Traditional | 04/08/1993SE |
| K924173 | Hemocard(Tm) ControlJCM · Traditional | 12/01/1992SE |
| K921681 | Criterion, Hemocue B-Hemoglobin ControlGGM · Traditional | 11/17/1992SE |
| K911981 | Hemocard Hemoglobin SGHM · Traditional | 10/09/1991SE |
| K910430 | Hemocard-AsGHM · Traditional | 04/15/1991SE |
| K910431 | Hemocard ControlJCM · Traditional | 03/11/1991SE |
| K905513 | Glyc-Affin(Tm)-GaLCP · Traditional | 01/15/1991SE |
| K904814 | Glyc-Affin GPLCP · Traditional | 12/26/1990SE |
| K902740 | Ldl-Direct ControlsJJY · Traditional | 12/07/1990SE |
| K901453 | Quik-Sep(R) Igm Rprotein G Affinity MethodDFT · Traditional | 04/12/1990SE |
| K883411 | Pg-Numeric(Tm)JHF · Traditional | 03/15/1989SE |
| K880673 | GHB Sample PaperLCP · Traditional | 11/22/1988SE |
| K873428 | Glyco-Probe GSPLCP · Traditional | 04/05/1988SE |
| K862638 | Visible-Chlamydia(Tm) Test SystemLJC · Traditional | 08/26/1986SE |
| K854712 | Visible-Herpes TM Test SystemGQO · Traditional | 05/20/1986SE |
| K843122 | Resolve-CsfDFI · Traditional | 11/30/1984SE |
| K842152 | Sickling Hemoglobin Controls, NormalGHM · Traditional | 09/09/1984SE |
| K841170 | Sickle HB AssayGHM · Traditional | 04/04/1984SE |
| K840011 | Resolve-HbGKA · Traditional | 02/04/1984SE |
| K830606 | Quik-Sep Igm Isolation SystemDFT · Traditional | 03/24/1983SE |
| K822867 | Glyc-Affin Glycohemoglobin AssayLCP · Traditional | 12/03/1982SE |
| K820630 | Quik-Sep Hemoglobin F Assay & ControlJPC · Traditional | 06/25/1982SE |
| K812318 | Lipo-Sep Cholesterol Audit System · Traditional | 09/01/1981SE |
| K810976 | Alpha-Thal Screen TM ControlLGL · Traditional | 05/29/1981SE |
| K810919 | Hemoglobin Electrophoresis ControlJBD · Traditional | 04/23/1981SE |
| K801771 | Alpha-Thal Screen 20 Test Kit & 100 KitLGL · Traditional | 01/16/1981SE |
| K802997 | Hdl-Cholesterol Control SerumJJX · Traditional | 12/22/1980SE |
| K801410 | Hemohlobin A2 Control-LyophilizedJPD · Traditional | 07/21/1980SE |
| K800794 | Fast Hemoglobin Control-LyophilizedLCP · Traditional | 04/29/1980SE |
| K791143 | Sickle-Cell F TestKQI · Traditional | 07/17/1979SE |
| K781851 | Hemoglobin, Testing SystemLCP · Traditional | 11/07/1978SE |
| K780998 | ScalpelGDX · Traditional | 07/27/1978SE |
| K771649 | Hemoglobin A2 Testing SystemJBD · Traditional | 10/07/1977SE |