KLR · Class II · 21 CFR 862.3555

FDA Product Code KLR: Enzyme Immunoassay, Lidocaine

Leading manufacturers include Syva Co., E.I. Dupont DE Nemours & Co., Inc. and Roche Diagnostics Corp..

17
Total
17
Cleared
59d
Avg days
1980
Since

FDA 510(k) Cleared Enzyme Immunoassay, Lidocaine Devices (Product Code KLR)

17 devices
1–17 of 17
Cleared Feb 20, 2004
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
K033809
Dade Behring, Inc.
Toxicology · 74d
Cleared Jan 12, 2004
ROCHE ONLINE TDM LIDOCAINE
K032334
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Aug 07, 1985
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Sep 26, 1984
STRATUS LIDOCAINE FLUOROMETRIC ENZYME
K843184
American Dade
Immunology · 44d
Cleared Dec 27, 1983
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 27, 1983
VALPROIC ACID ANALYTICAL TEST PACK
K833381
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Dec 08, 1983
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623
Syva Co.
Toxicology · 55d
Cleared Oct 14, 1983
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY
K832799
Syva Co.
Toxicology · 57d
Cleared May 27, 1983
EMIT QST LIDOCAINE ASSAY
K831354
Syva Co.
Toxicology · 31d
Cleared Jan 28, 1983
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY
K823887
Syva Co.
Toxicology · 32d
Cleared Jan 12, 1983
ADVANCE EMIT CAD LIDOCAINE ASSAY
K823866
Syva Co.
Chemistry · 20d
Cleared Oct 31, 1980
CYBREX LIDOCAINE
K802131
Abbott Laboratories
Toxicology · 57d
Cleared Jun 09, 1980
EMIT DISOPYRAMIDE ASSAY
K801204
Syva Co.
Chemistry · 21d

About Product Code KLR - Regulatory Context