Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Electrophoresis combined with cholesterol measurement via esterase-oxidase for HDL determination is a laboratory method that separates lipoprotein fractions by electrophoresis and then quantifies HDL cholesterol using an enzymatic reaction, used in lipid profiling for cardiovascular risk assessment. It is FDA Class 1, requiring only general controls and no premarket notification. The product code is LBT, regulated under 21 CFR 862.1475, in the Clinical Chemistry specialty. No special flags apply.
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Basic Information
- Product Code
- LBT
- 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 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000568 | HDL CHOLESTEROL PLUS | Aug 04, 2000 | Substantially Equivalent | Roche Diagnostics Corp. |
| K990250 | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 | Jun 18, 1999 | Substantially Equivalent | Morax |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Oct 27, 1997 | Substantially Equivalent | Morax |
| K904035 | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | Nov 09, 1990 | Substantially Equivalent | Helena Laboratories |
| K894366 | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 | Aug 31, 1989 | Substantially Equivalent | Helena Laboratories |
| K882368 | REP HDL ELECTROPHORESIS METHOD | Aug 08, 1988 | Substantially Equivalent | Helena Laboratories |
| K873547 | TITAN GEL HDL CHOLESTEROL KIT | Oct 02, 1987 | Substantially Equivalent | Helena Laboratories |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | Jun 15, 1979 | Substantially Equivalent | Gelman Sciences, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.