Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187
FDA 510(k) K894366 · Helena Laboratories
510(k) numberK894366
Submission
- Device name
- Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- July 14, 1989
- Decision date
- August 31, 1989
- 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 |
| 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 |
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Questions and answers
When was Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187 cleared by the FDA?
Rep HDL-8 Kit, No. 3188, Rep HDL-16 Kit, No. 3187 (K894366) received a 510(k) decision of Substantially Equivalent on August 31, 1989, 48 days after the submission was received.
What is the product code of K894366?
The FDA product code is LBT – Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.