Titan Gel HDL Cholesterol Kit
FDA 510(k) K873547 · Helena Laboratories
510(k) numberK873547
Submission
- Device name
- Titan Gel HDL Cholesterol Kit
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- September 1, 1987
- Decision date
- October 2, 1987
- 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 |
| K790791 | Electrophoresis Reagent Set, HDLLBT · Traditional | Gelman Sciences, Inc. | 06/15/1979SE |
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Questions and answers
When was Titan Gel HDL Cholesterol Kit cleared by the FDA?
Titan Gel HDL Cholesterol Kit (K873547) received a 510(k) decision of Substantially Equivalent on October 2, 1987, 31 days after the submission was received.
What is the product code of K873547?
The FDA product code is LBT – Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.