Product code LBT— Clinical Chemistry
ELECTROPHORESIS REAGENT SET, HDL
- Classification name
- Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code LBT
FDA has cleared devices under product code LBT between 1979 and 2000, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2000
- 1999
- 1997
- 1990
- 1989
- 1988
- 1987
- 1979
Top applicants under product code LBT
Recent clearances under product code LBT
- K000568 — HDL CHOLESTEROL PLUS
- 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
- K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT
- K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
- K882368 — REP HDL ELECTROPHORESIS METHOD
- K873547 — TITAN GEL HDL CHOLESTEROL KIT
- K790791 — ELECTROPHORESIS REAGENT SET, HDL
Data sourced from openFDA. This site is unofficial and independent of the FDA.