KLQ · Class II · 21 CFR 862.3035

FDA Product Code KLQ: Radioimmunoassay, Amikacin

Leading manufacturers include Diagnostic Products Corp., Miles Laboratories, Inc. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

20
Total
20
Cleared
38d
Avg days
1978
Since

FDA 510(k) Cleared Radioimmunoassay, Amikacin Devices (Product Code KLQ)

20 devices
1–20 of 20
Cleared Jun 09, 2004
RANDOX AMIKACIN
K033884
Randox Laboratories, Ltd.
Chemistry · 177d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Sep 12, 1984
AMIKACIN ANALYTICAL TEST PACK ACA
K843211
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 28d
Cleared Mar 23, 1984
EMIT QST AMIKACIN ASSAY
K840193
Syva Co.
Toxicology · 65d
Cleared Aug 31, 1983
STRATUS AMIKACIN FLUOROMETRIC
K832336
American Dade
Chemistry · 44d
Cleared Sep 28, 1982
EMIT-AMD AMIKACIN ASSAY
K822657
Dade Behring, Inc.
Chemistry · 25d
Cleared Jun 25, 1982
MACRO-VUE CARD TEST, AMIKACIN
K821771
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 9d
Cleared Apr 09, 1982
COAT-A-COUNT AMIKACIN IRA
K820781
Diagnostic Products Corp.
Toxicology · 17d
Cleared Jan 12, 1982
AMIKACIN FLUORESCENT IMMUNOASSAY
K813541
American Diagnostic Corp.
Toxicology · 22d
Cleared Apr 29, 1981
AMES TDA TM AMIKACIN TEST
K811026
Miles Laboratories, Inc.
Toxicology · 13d
Cleared Nov 12, 1980
CYBREX AMIKACIN
K802669
Abbott Laboratories
Chemistry · 16d
Cleared May 28, 1980
AMES TDA AMIKACIN
K801130
Miles Laboratories, Inc.
Toxicology · 16d
Cleared Apr 10, 1978
AMIKACIN
K780494
Diagnostic Products Corp.
Toxicology · 14d

About Product Code KLQ - Regulatory Context