LBTClass I
Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Clinical Chemistry · 21 CFR 862.1475
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances8All time
Recent MDR events
1 adverse event reports on file
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Roche Diagnostics Corp.Aug 4, 2000
K000568 · HDL CHOLESTEROL PLUS
- MoraxJun 18, 1999
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
- MoraxOct 27, 1997
K972015 · HYDRAGEL 7,15,30, CHOL-HDL KIT
- Helena LaboratoriesNov 9, 1990
K904035 · REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- Helena LaboratoriesAug 31, 1989
K894366 · REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
- Helena LaboratoriesAug 8, 1988
K882368 · REP HDL ELECTROPHORESIS METHOD
- Helena LaboratoriesOct 2, 1987
K873547 · TITAN GEL HDL CHOLESTEROL KIT
- Gelman Sciences, Inc.Jun 15, 1979
K790791 · ELECTROPHORESIS REAGENT SET, HDL