Hydragel 7,15,30, Chol-Hdl Kit
FDA 510(k) K972015 · Morax
510(k) numberK972015
Submission
- Device name
- Hydragel 7,15,30, Chol-Hdl Kit
- Applicant
- Morax
Chelsea, MI, US - Received
- May 30, 1997
- Decision date
- October 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LBT – Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LBT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000568 | HDL Cholesterol PlusLBT · Traditional | Roche Diagnostics Corp. | 08/04/2000SE |
| K990250 | Hydragel Ldl/Hdl Chol Direct Kit-P.N. 4005, Hydragel 7 Ldl/Hdl Chol Direct Kit-P.N.…LBT · Traditional | Morax | 06/18/1999SE |
| K904035 | Rep Ultra Hdl,Vldl/Ldl Cholesterol SystemLBT · Traditional | Helena Laboratories | 11/09/1990SE |
| K894366 | Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187LBT · Traditional | Helena Laboratories | 08/31/1989SE |
| K882368 | Rep HDL Electrophoresis MethodLBT · Traditional | Helena Laboratories | 08/08/1988SE |
| K873547 | Titan Gel HDL Cholesterol KitLBT · Traditional | Helena Laboratories | 10/02/1987SE |
| K790791 | Electrophoresis Reagent Set, HDLLBT · Traditional | Gelman Sciences, Inc. | 06/15/1979SE |
More from Gelman Sciences, Inc.
| 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 |
| 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 7,15,30, Chol-Hdl Kit cleared by the FDA?
Hydragel 7,15,30, Chol-Hdl Kit (K972015) received a 510(k) decision of Substantially Equivalent on October 27, 1997, 150 days after the submission was received.
What is the product code of K972015?
The FDA product code is LBT – Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.