LEH · Class II · 21 CFR 862.3950

FDA Product Code LEH: Radioimmunoassay, Vancomycin

Leading manufacturers include Abbott Laboratories, Roche Diagnostic Systems, Inc. and Biokit, S.A..

31
Total
31
Cleared
88d
Avg days
1981
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Radioimmunoassay, Vancomycin Devices (Product Code LEH)

31 devices
1–24 of 31
Cleared Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
K222439
Siemens Healthcare Diagnostics, Inc.
Toxicology · 361d
Cleared Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
K160202
Siemens Healthcare Diagnostics, Inc.
Toxicology · 90d
Cleared Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
K152245
Roche Diagnostics Operations (Rdo)
Chemistry · 151d
Cleared Aug 29, 2013
ARCHITECT IVANCOMYCIN
K123947
Biokit, S.A.
Toxicology · 251d
Cleared Mar 19, 2008
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
K072036
Biokit, S.A.
Toxicology · 238d
Cleared Dec 05, 2006
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
K063045
Diagnostic Products Corp.
Toxicology · 62d
Cleared May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
K060586
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 01, 2005
QMS VANCOMYCIN
K050419
Seradyn, Inc.
Toxicology · 42d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III
K043386
Ortho-Clinical Diagnostics, Inc.
Toxicology · 60d
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811
Microgenics Corp.
Toxicology · 76d
Cleared May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
K020692
Dade Behring, Inc.
Toxicology · 67d
Cleared Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
K013076
Beckman Coulter, Inc.
Toxicology · 89d
Cleared Nov 06, 1998
VANCOMYCIN EIA ASSAY
K983280
Diagnostic Reagents, Inc.
Toxicology · 49d
Cleared Jan 13, 1997
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K964587
Bayer Corp.
Toxicology · 59d
Cleared Sep 13, 1996
VANCOMYCIN FLEX REAGENT CARTRIDGE
K963267
Dade Intl., Inc.
Toxicology · 24d
Cleared May 09, 1996
AXSYM VANCOMYCIN II
K955851
Abbott Laboratories
Toxicology · 134d
Cleared Feb 16, 1996
VANCOMYCIN FPIA REAGENT SET
K955716
Sigma Diagnostics, Inc.
Toxicology · 63d
Cleared Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Jun 19, 1995
CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY
K951059
Ciba Corning Diagnostics Corp.
Toxicology · 104d
Cleared Jun 21, 1994
AXSYM VANCOMYCIN
K940595
Abbott Laboratories
Toxicology · 131d
Cleared Dec 11, 1992
OPUS(R) VANCOMYCIN
K924957
Pb Diagnostic Systems, Inc.
Toxicology · 72d
Cleared May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Apr 19, 1990
MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
K900708
Innotron of Oregon, Inc.
Toxicology · 66d
Cleared May 22, 1989
ACA VANCOMYCIN (VANC) METHOD
K892900
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d

About Product Code LEH - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code LEH since 1981, with 31 receiving FDA clearance (average review time: 88 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.