Morax
Medical device manufacturer in Norcross, GA.
12510(k) clearances
0PMA approvals
0recalls
Device types
- CFF Immunoelectrophoretic, Immunoglobulins, (G… 3
- LBT Electrophoresis, Cholesterol Via… 2
- JHO Electrophoretic Separation, Lipoproteins 2
- CEF Electrophoretic, Protein Fractionation 1
- LCP Assay, Glycosylated Hemoglobin 1
- JKM Immunochemical, Bence-Jones Protein 1
- JBD System, Analysis, Electrophoretic Hemoglobin 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K033277 | Hydragel CSF Isofocusing KitsCFF · Special | 11/04/2003SE |
| K012789 | Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123JHO · Special | 01/17/2002SE |
| K992148 | Hydragel-Mini Iso-Ck Kit, Hydragel Iso-Ck Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-Ck…CGS · Traditional | 12/29/1999SE |
| K991362 | Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E)…JBD · Traditional | 06/21/1999SE |
| K990250 | Hydragel Ldl/Hdl Chol Direct Kit-P.N. 4005, Hydragel 7 Ldl/Hdl Chol Direct Kit-P.N.…LBT · Traditional | 06/18/1999SE |
| K981048 | Hydragel 6 CSF KitCFF · Traditional | 10/07/1998SE |
| K974854 | Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207JHO · Traditional | 10/07/1998SE |
| K972591 | Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitJKM · Traditional | 03/04/1998SE |
| K972015 | Hydragel 7,15,30, Chol-Hdl KitLBT · Traditional | 10/27/1997SE |
| K963844 | Hydragel 15 HB A1C KitLCP · Traditional | 04/22/1997SE |
| K960029 | Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein KitCEF · Traditional | 07/17/1996SE |
| K960669 | Hydragel If, 6 If, 12 If Penta Kits/Hydragel If, Double If, 2 If, & 4 If KitsCFF · Traditional | 07/12/1996SE |