Turbidimetric Method, Lipoproteins
Turbidimetric Method for Lipoproteins is a clinical chemistry test system that measures lipoprotein concentrations by quantifying turbidity resulting from lipoprotein-reagent interactions, supporting lipid panel analysis and cardiovascular risk stratification. It is classified as FDA Class 1 (lowest risk), governed only by general controls. The product code is JHN, regulated under 21 CFR 862.1475, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JHN
- Device Class
- FDA class 1
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950383 | APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT | Sep 15, 1995 | Substantially Equivalent | Randox Laboratories, Ltd. |
| K950382 | APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT | Sep 15, 1995 | Substantially Equivalent | Randox Laboratories, Ltd. |
| K952615 | WAKO AUTOKIT APO A1 | Sep 08, 1995 | Substantially Equivalent | Wako Chemicals USA, Inc. |
| K952425 | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT | Jul 05, 1995 | Substantially Equivalent | Olympus America, Inc. |
| K952466 | OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT | Jun 05, 1995 | Substantially Equivalent | Olympus America, Inc. |
| K932606 | APOLIPOPROTIEN A-1 (APO A-1) | Jun 02, 1994 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K932603 | APOLIPOPROTIEN B (APO B) | Jun 02, 1994 | Substantially Equivalent | Sigma Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.