LBT
8 FDA 510(k) clearances · Product code
70 daysmedian time to decision
164 days90th percentile
8clearances measured
FDA profile
- Official device name
- Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HDL CHOLESTEROL PLUS (K000568) | Roche Diagnostics Corp. | 2000-08-04 |
| 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 (K990250) | Morax | 1999-06-18 |
| HYDRAGEL 7,15,30, CHOL-HDL KIT (K972015) | Morax | 1997-10-27 |
| REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM (K904035) | Helena Laboratories | 1990-11-09 |
| REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 (K894366) | Helena Laboratories | 1989-08-31 |
| REP HDL ELECTROPHORESIS METHOD (K882368) | Helena Laboratories | 1988-08-08 |
| TITAN GEL HDL CHOLESTEROL KIT (K873547) | Helena Laboratories | 1987-10-02 |
| ELECTROPHORESIS REAGENT SET, HDL (K790791) | Gelman Sciences, Inc. | 1979-06-15 |
Track LBT automatically
Every clearance here is in the API, with alerts when new ones post.