Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis Cholesterol
FDA 510(k) K980650 · Helena Laboratories
510(k) numberK980650
Submission
- Device name
- Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis Cholesterol
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- February 19, 1998
- Decision date
- May 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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 |
| K012789 | Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123JHO · Special | Morax | 01/17/2002SE |
| 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 |
| K971157 | Macralp(A) Enzyme Immunoassay KitJHO · Traditional | Strategic Diagnostics, Inc. | 04/15/1998SE |
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Questions and answers
When was Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis Cholesterol cleared by the FDA?
Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis Cholesterol (K980650) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 71 days after the submission was received.
What is the product code of K980650?
The FDA product code is JHO – Electrophoretic Separation, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.