LBT — Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl Class I
FDA Device Classification
Classification Details
- Product Code
- LBT
- Device Class
- Class I
- Regulation Number
- 862.1475
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K000568 | roche diagnostics | HDL CHOLESTEROL PLUS | August 4, 2000 |
| K990250 | morax | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P | June 18, 1999 |
| K972015 | morax | HYDRAGEL 7,15,30, CHOL-HDL KIT | October 27, 1997 |
| K904035 | helena laboratories | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | November 9, 1990 |
| K894366 | helena laboratories | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 | August 31, 1989 |
| K882368 | helena laboratories | REP HDL ELECTROPHORESIS METHOD | August 8, 1988 |
| K873547 | helena laboratories | TITAN GEL HDL CHOLESTEROL KIT | October 2, 1987 |
| K790791 | gelman sciences | ELECTROPHORESIS REAGENT SET, HDL | June 15, 1979 |