Apolipoprotein B Immunoturbidiemetric Kit
FDA 510(k) K950382 · Randox Laboratories, Ltd.
510(k) numberK950382
Submission
- Device name
- Apolipoprotein B Immunoturbidiemetric Kit
- Applicant
- Randox Laboratories, Ltd.
Crumlin, Co. Antrim, IE - Received
- January 31, 1995
- Decision date
- September 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JHN – Turbidimetric Method, Lipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950383 | Apolipoprotein A-I Immunoturbidimetric KitJHN · Traditional | Randox Laboratories, Ltd. | 09/15/1995SE |
| K952615 | Wako Autokit Apo A1JHN · Traditional | Wako Chemicals USA, Inc. | 09/08/1995SE |
| K952425 | Olympus Apolipoprotein A1 Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 07/05/1995SE |
| K952466 | Olympus Apolipoprotein B Immunoturbidimetric ReagentJHN · Traditional | Olympus America, Inc. | 06/05/1995SE |
| K932606 | Apolipoprotien A-1 (Apo A-1)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
| K932603 | Apolipoprotien B (Apo B)JHN · Traditional | Sigma Diagnostics, Inc. | 06/02/1994SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 01/23/2026SE |
| K221550 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | 10/05/2023SE |
| K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATDJG · Traditional | 10/05/2023SE |
| K230890 | ISE ElectrodesCEM · Special | 09/08/2023SE |
| K182042 | Randox Calcium (Ca)CJY · Traditional | 10/23/2018SE |
| K162200 | Randox RX Daytona Plus Magnesium (MG)JGJ · Traditional | 04/28/2017SE |
| K162275 | Randox RX Daytona Plus Alkaline Phosphatase (ALP)CJE · Traditional | 04/21/2017SE |
| K161691 | Direct LDL Cholesterol (LDL)MRR · Traditional | 03/20/2017SE |
| K152085 | Liquid CO2-2 (LCO2-2)KHS · Traditional | 02/24/2016SE |
| K152343 | Direct BilirubinJFM · Traditional | 02/16/2016SE |
Questions and answers
When was Apolipoprotein B Immunoturbidiemetric Kit cleared by the FDA?
Apolipoprotein B Immunoturbidiemetric Kit (K950382) received a 510(k) decision of Substantially Equivalent on September 15, 1995, 227 days after the submission was received.
What is the product code of K950382?
The FDA product code is JHN – Turbidimetric Method, Lipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.