Product code LEH— Clinical Toxicology
ACA VANCOMYCIN (VANC) METHOD
- Classification name
- Radioimmunoassay, Vancomycin
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Total cleared
- 31
- First cleared
- Most recent
Market context for product code LEH
FDA has cleared devices under product code LEH between 1981 and 2023, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2023
- 2016
- 2013
- 2008
- 2006
- 2005
- 2003
- 2002
- 2001
- 1998
- 1997
- 1996
- 1995
- 1994
- 1992
Top applicants under product code LEH
Recent clearances under product code LEH
- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K152245 — ONLINE TDM Vancomycin Gen.3
- K123947 — ARCHITECT IVANCOMYCIN
- K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
- K060586 — ENZYME IMMUNOASSAY, VANCOMYCIN
- K050419 — QMS VANCOMYCIN
- K043386 — VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
- K032811 — CEDIA VANCOMYCIN ASSAY
- K020692 — EMIT 2000 VANCOMYCIN ASSAY
- K013076 — SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
- K983280 — VANCOMYCIN EIA ASSAY
- K964587 — VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
- K963267 — VANCOMYCIN FLEX REAGENT CARTRIDGE
- K955851 — AXSYM VANCOMYCIN II
- K955716 — VANCOMYCIN FPIA REAGENT SET
- K953528 — ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
- K951059 — CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
- K945125 — DUPONT ACA VANCOMYCIN (VANC) METHOD
- K940595 — AXSYM VANCOMYCIN
- K924957 — OPUS(R) VANCOMYCIN
- K901759 — COBAS-FP REAGENTS FOR VANCOMYCIN
- K900708 — MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
- K892900 — ACA VANCOMYCIN (VANC) METHOD
- K881040 — EMIT VANCOMYCIN ASSAY
- K874438 — STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
- K872579 — INNOFLUOR VANCOMYCIN REAGENT SET
- K822308 — VANCOMYCIN FLUORESCENT IMMUNOASSAY
- K821136 — TDX TM STREPTOMYCIN
- K813218 — TDX VANCOMYCIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.