FDA Product Code
FDA Product Code LBT — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1475
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K000568 | HDL CHOLESTEROL PLUS | Roche Diagnostics Corp. | 2000-08-04 | Traditional | PDF ↗ |
| 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 | 1999-06-18 | Traditional | PDF ↗ |
| K972015 | HYDRAGEL 7,15,30, CHOL-HDL KIT | Morax | 1997-10-27 | Traditional | PDF ↗ |
| K904035 | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | Helena Laboratories | 1990-11-09 | Traditional | PDF ↗ |
| K894366 | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 | Helena Laboratories | 1989-08-31 | Traditional | PDF ↗ |
| K882368 | REP HDL ELECTROPHORESIS METHOD | Helena Laboratories | 1988-08-08 | Traditional | PDF ↗ |
| K873547 | TITAN GEL HDL CHOLESTEROL KIT | Helena Laboratories | 1987-10-02 | Traditional | PDF ↗ |
| K790791 | ELECTROPHORESIS REAGENT SET, HDL | Gelman Sciences, Inc. | 1979-06-15 | Traditional | PDF ↗ |
Product code LBT · Class I · Clinical Chemistry. Data: openFDA.