Electrophoresis Reagent Set, HDL
FDA 510(k) K790791 · Gelman Sciences, Inc.
510(k) numberK790791
Submission
- Device name
- Electrophoresis Reagent Set, HDL
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- April 24, 1979
- Decision date
- June 15, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K972015 | Hydragel 7,15,30, Chol-Hdl KitLBT · Traditional | Morax | 10/27/1997SE |
| 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 |
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 Electrophoresis Reagent Set, HDL cleared by the FDA?
Electrophoresis Reagent Set, HDL (K790791) received a 510(k) decision of Substantially Equivalent on June 15, 1979, 52 days after the submission was received.
What is the product code of K790791?
The FDA product code is LBT – Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.