LEH · Class II · 21 CFR 862.3950

FDA Product Code LEH: Radioimmunoassay, Vancomycin

Leading manufacturers include Abbott Laboratories, Biokit, S.A. and Siemens Healthcare Diagnostics, Inc..

31
Total
31
Cleared
88d
Avg days
1981
Since
31 devices
25–31 of 31
Cleared Apr 19, 1988
EMIT VANCOMYCIN ASSAY
K881040
Syva Co.
Toxicology · 39d
Cleared Jan 21, 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
K874438
Baxter Healthcare Corp
Chemistry · 85d
Cleared Aug 17, 1987
INNOFLUOR VANCOMYCIN REAGENT SET
K872579
Innotron of Oregon, Inc.
Chemistry · 48d
Cleared Aug 16, 1982
VANCOMYCIN FLUORESCENT IMMUNOASSAY
K822308
American Diagnostic Corp.
Toxicology · 13d
Cleared May 13, 1982
TDX TM STREPTOMYCIN
K821136
Abbott Laboratories
Hematology · 23d
Cleared Dec 08, 1981
TDX VANCOMYCIN
K813218
Abbott Laboratories
Toxicology · 29d