DKJ · Class II · 21 CFR 862.3830

FDA Product Code DKJ: Colorimetry, Salicylate

Leading manufacturers include Em Diagnostic Systems, Inc., Abbott Laboratories and Syva Co..

29
Total
29
Cleared
66d
Avg days
1981
Since

FDA 510(k) Cleared Colorimetry, Salicylate Devices (Product Code DKJ)

29 devices
1–24 of 29
Cleared Feb 15, 2002
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
K014173
Beckman Coulter, Inc.
Toxicology · 57d
Cleared Aug 13, 2001
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
K011878
Syva Co.
Toxicology · 59d
Cleared Aug 08, 1995
AXSYM SALICYLATE
K951290
Abbott Laboratories
Toxicology · 140d
Cleared Jan 25, 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Nov 09, 1990
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD
K904301
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 51d
Cleared Jul 16, 1990
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI)
K902356
Eastman Kodak Company
Chemistry · 48d
Cleared Oct 29, 1987
EASY-TEST SALICYLATE (SAL) #16691
K873425
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
K872321
Em Diagnostic Systems, Inc.
Chemistry · 72d
Cleared Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
K872330
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Nov 27, 1984
TDX SALICYLATE
K844070
Abbott Laboratories
Chemistry · 40d
Cleared Mar 23, 1984
DETERMIN. OF SALICYLATE IN SERUM/PLAST
K840243
Sigma Chemical Co.
Chemistry · 63d

About Product Code DKJ - Regulatory Context