LEH — Radioimmunoassay, Vancomycin Class II
FDA product code LEH covers "Radioimmunoassay, Vancomycin", a Class II medical device regulated under 21 CFR 862.3950. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LEH
- Device Class
- Class II
- Regulation Number
- 862.3950
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222439 | siemens healthcare diagnostics | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | August 8, 2023 |
| K160202 | siemens healthcare diagnostics | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | April 27, 2016 |
| K152245 | roche diagnostics operations (rdo) | ONLINE TDM Vancomycin Gen.3 | January 8, 2016 |
| K123947 | biokit | ARCHITECT IVANCOMYCIN | August 29, 2013 |
| K072036 | biokit | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P | March 19, 2008 |
| K063045 | diagnostic products | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | December 5, 2006 |
| K060586 | roche diagnostics | ENZYME IMMUNOASSAY, VANCOMYCIN | May 11, 2006 |
| K050419 | seradyn | QMS VANCOMYCIN | April 1, 2005 |
| K043386 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VE | February 7, 2005 |
| K032811 | microgenics | CEDIA VANCOMYCIN ASSAY | November 24, 2003 |
| K020692 | dade behring | EMIT 2000 VANCOMYCIN ASSAY | May 10, 2002 |
| K013076 | beckman coulter | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR | December 12, 2001 |
| K983280 | diagnostic reagents | VANCOMYCIN EIA ASSAY | November 6, 1998 |
| K964587 | bayer | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | January 13, 1997 |
| K963267 | dade intl | VANCOMYCIN FLEX REAGENT CARTRIDGE | September 13, 1996 |
| K955851 | abbott laboratories | AXSYM VANCOMYCIN II | May 9, 1996 |
| K955716 | sigma diagnostics | VANCOMYCIN FPIA REAGENT SET | February 16, 1996 |
| K953528 | roche diagnostic systems | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN | September 12, 1995 |
| K951059 | ciba corning diagnostics | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY | June 19, 1995 |
| K945125 | du pont | DUPONT ACA VANCOMYCIN (VANC) METHOD | March 10, 1995 |