Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123
FDA 510(k) K012789 · Morax
510(k) numberK012789
Submission
- Device name
- Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123
- Applicant
- Morax
Chelsea, MI, US - Received
- August 20, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHO – Electrophoretic Separation, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022333 | Spife LIPPOROTEIN-12, Model 3344JHO · Traditional | Helena Laboratories | 08/15/2002SE |
| K022053 | Hydragel 7 Lipoprotein(E), PN 4114 & Hydragel Lipoprotein(E) 15/30 PN 4134JHO · Special | Sebia | 07/12/2002SE |
| K013662 | Modification to Lipoprint System, LDL SubfractionsJHO · Special | Quantimetrix Corp. | 03/08/2002SE |
| K013466 | Spife 2000/3000 Lipoprotein; Model# 3340, 3341, 3342, 3343JHO · Traditional | Helena Laboratories | 12/21/2001SE |
| K010337 | Lipoprint System, LDL SubfractionsJHO · Traditional | Quantimetrix Corp. | 07/25/2001SE |
| K000603 | Spife Cholesterol Profile KitJHO · Traditional | Helena Laboratories | 04/17/2000SE |
| K992971 | Rep Cholesterol Profile KitJHO · Traditional | Helena Laboratories | 10/18/1999SE |
| K974854 | Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207JHO · Traditional | Morax | 10/07/1998SE |
| K980650 | Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis CholesterolJHO · Traditional | Helena Laboratories | 05/01/1998SE |
| K971157 | Macralp(A) Enzyme Immunoassay KitJHO · Traditional | Strategic Diagnostics, Inc. | 04/15/1998SE |
More from Strategic Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K033277 | Hydragel CSF Isofocusing KitsCFF · Special | 11/04/2003SE |
| 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 Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123 cleared by the FDA?
Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123 (K012789) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 150 days after the submission was received.
What is the product code of K012789?
The FDA product code is JHO – Electrophoretic Separation, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.