KLB · Class II · 21 CFR 862.3900

FDA Product Code KLB: Radioimmunoassay, Tobramycin

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

23
Total
23
Cleared
46d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Tobramycin Devices (Product Code KLB)

23 devices
1–23 of 23
Cleared Jun 09, 2006
ONLINE TDM TOBRAMYCIN
K060853
Roche Diagnostics Corp.
Toxicology · 72d
Cleared Aug 20, 2001
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312
Diagnostic Products Corp.
Toxicology · 28d
Cleared Oct 26, 1990
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 37d
Cleared Aug 22, 1990
IL TOBRAMYCIN ASSAY
K903192
Instrumentation Laboratory CO
Chemistry · 34d
Cleared Aug 21, 1989
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913
Technicon Instruments Corp.
Toxicology · 83d
Cleared Jul 01, 1988
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294
Syva Co.
Toxicology · 29d
Cleared Nov 13, 1987
EMIT TOBRAMYCIN ASSAY
K874223
Syva Co.
Toxicology · 28d
Cleared Jul 22, 1985
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 28d
Cleared Oct 27, 1983
TOBRAMYCIN ANALYTICAL TEST PACK-ACA
K832985
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 55d
Cleared Oct 18, 1982
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858
Diagnostic Products Corp.
Chemistry · 21d
Cleared Mar 17, 1981
MACRO-VUE CARD TEST
K810597
Bd Becton Dickinson Vacutainer Systems Preanalytic
Toxicology · 11d
Cleared Oct 17, 1979
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
K791596
Bio-Rad
Toxicology · 63d
Cleared Sep 04, 1979
QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO
K791502
Bio-Rad
Toxicology · 27d
Cleared Aug 16, 1979
AMES TDA/TOBRAMYCIN
K791435
Miles Laboratories, Inc.
Toxicology · 16d
Cleared Dec 22, 1976
TOBRAMYCIN RIA KIT
K760967
Diagnostic Products Corp.
Immunology · 48d

About Product Code KLB - Regulatory Context