FDA Product Code LEH: Radioimmunoassay, Vancomycin
Leading manufacturers include Abbott Laboratories, Roche Diagnostic Systems, Inc. and Siemens Healthcare Diagnostics, Inc..
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
Cleared
Aug 08, 2023
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
Siemens Healthcare Diagnostics, Inc.
Toxicology
361d
Cleared
Apr 27, 2016
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Siemens Healthcare Diagnostics, Inc.
Toxicology
90d
Cleared
Dec 05, 2006
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
Diagnostic Products Corp.
Toxicology
62d
Cleared
May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
Roche Diagnostics Corp.
Toxicology
65d
Cleared
May 10, 2002
EMIT 2000 VANCOMYCIN ASSAY
Dade Behring, Inc.
Toxicology
67d
Cleared
Dec 12, 2001
SYNCHRON SYSTEMS VANCOMYCIN REAGENT
Beckman Coulter, Inc.
Toxicology
89d
Cleared
May 09, 1996
AXSYM VANCOMYCIN II
Abbott Laboratories
Toxicology
134d
Cleared
Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
Roche Diagnostic Systems, Inc.
Toxicology
47d
Cleared
Jun 21, 1994
AXSYM VANCOMYCIN
Abbott Laboratories
Toxicology
131d
Cleared
May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
Roche Diagnostic Systems, Inc.
Chemistry
14d
Cleared
May 22, 1989
ACA VANCOMYCIN (VANC) METHOD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology
32d
Cleared
Apr 19, 1988
EMIT VANCOMYCIN ASSAY
Syva Co.
Toxicology
39d
Cleared
Jan 21, 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
Baxter Healthcare Corp
Chemistry
85d
Cleared
May 13, 1982
TDX TM STREPTOMYCIN
Abbott Laboratories
Hematology
23d
Cleared
Dec 08, 1981
TDX VANCOMYCIN
Abbott Laboratories
Toxicology
29d
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.