Panels › Clinical Chemistry › Product code LBT · Class 1
Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
Regulation 862.1475
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LBT
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 4 | 0 |
| Morax | 2 | 0 |
| Gelman Sciences, Inc. | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2000 | K000568 | HDL CHOLESTEROL PLUS Roche Diagnostics Corp. | LBT |
| Jun 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 Morax | LBT |
| Oct 27, 1997 | K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT Morax | LBT |
| Nov 9, 1990 | K904035 | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM Helena Laboratories | LBT |
| Aug 31, 1989 | K894366 | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 Helena Laboratories | LBT |
| Aug 8, 1988 | K882368 | REP HDL ELECTROPHORESIS METHOD Helena Laboratories | LBT |
| Oct 2, 1987 | K873547 | TITAN GEL HDL CHOLESTEROL KIT Helena Laboratories | LBT |
| Jun 15, 1979 | K790791 | ELECTROPHORESIS REAGENT SET, HDL Gelman Sciences, Inc. | LBT |
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