Colorimetric Method, Lipoproteins
Colorimetric Method for Lipoproteins is a clinical chemistry test system employing colorimetric reactions to quantify lipoprotein fractions such as HDL and LDL in serum, used in lipid profiling and assessment of cardiovascular risk. It is classified as FDA Class 1 (lowest risk), subject only to general controls including proper labeling and manufacturing standards. The product code is JHM, 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
- JHM
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K120662 | PICCOLO HDL-CAPILLARY TEST SYSTEM | Apr 24, 2012 | Substantially Equivalent | Abaxis, Inc. |
| K081300 | DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE | Jul 02, 2008 | Substantially Equivalent | Siemens Healthcare Diagnostics |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Feb 21, 2008 | Substantially Equivalent | Dade Behring, Inc. |
| K032798 | DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A | Oct 30, 2003 | Substantially Equivalent | Dade Behring, Inc. |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Sep 30, 2002 | Substantially Equivalent | Jas Diagnostics, Inc. |
| K983849 | DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE | Jan 11, 1999 | Substantially Equivalent | Dade Behring, Inc. |
| K902935 | ROCHE COBAS READY HDL CHOLESTEROL REAGENT | Sep 27, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K841056 | HDL PRECIPITANT REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K780173 | LYPOPROTEIN CHOLESTEROL TEST KIT | May 03, 1978 | Substantially Equivalent | Environmental Chemical Specialties |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.