Hydragel CSF Isofocusing Kits
FDA 510(k) K033277 · Morax
510(k) numberK033277
Submission
- Device name
- Hydragel CSF Isofocusing Kits
- Applicant
- Morax
Norcross, GA, US - Received
- October 10, 2003
- Decision date
- November 4, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | Sebia | 01/11/2018SE |
| K161928 | Capi 3 Immunotyping, Capillarys 3 Tera, It/If ControlCFF · Traditional | Sebia | 12/21/2016SE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCINGCFF · Special | Sebia | 01/08/2015SE |
| K120169 | Interlab Ife Test Using G 26 Ver. 2.0 InstrumentCFF · Traditional | Grifols USA, LLC | 08/24/2012SE |
| K111369 | The Helena V8 Immunodisplacement KitCFF · Traditional | Helena Laboratories Uk, Ltd. | 06/26/2012SE |
| K103757 | Immunofixation Electrophoresis Test Using Interlab G26 InstrumentCFF · Traditional | Grifols | 10/13/2011SE |
| K082085 | Capillarys Immunotyping, Model 2100CFF · Traditional | Sebia | 04/17/2009SE |
More from Sebia
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
Questions and answers
When was Hydragel CSF Isofocusing Kits cleared by the FDA?
Hydragel CSF Isofocusing Kits (K033277) received a 510(k) decision of Substantially Equivalent on November 4, 2003, 25 days after the submission was received.
What is the product code of K033277?
The FDA product code is CFF – Immunoelectrophoretic, Immunoglobulins, (G, A, M), a Class II (moderate risk) device regulated under 21 CFR 866.5510.