Gelman Lipoprotein FRS Set. P/N 51213
FDA 510(k) K791606 · Gelman Sciences, Inc.
510(k) numberK791606
Submission
- Device name
- Gelman Lipoprotein FRS Set. P/N 51213
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- August 20, 1979
- Decision date
- September 17, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
| K980650 | Rep Cholesterol Profile TEMPLATE-30, -16, -8; Rep Vis CholesterolJHO · Traditional | Helena Laboratories | 05/01/1998SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K946190 | Drug Dispensing SpikeFMF · Traditional | 03/17/1995SE |
| K943127 | Pharmassure Large Volume Transfer FiltersFPB · Traditional | 09/29/1994SE |
| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
Questions and answers
When was Gelman Lipoprotein FRS Set. P/N 51213 cleared by the FDA?
Gelman Lipoprotein FRS Set. P/N 51213 (K791606) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 28 days after the submission was received.
What is the product code of K791606?
The FDA product code is JHO – Electrophoretic Separation, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.