DLG · Class I · 21 CFR 862.2250

FDA Product Code DLG: Coating, Liquid, Glc

Leading manufacturers include Colony Laboratories, Inc., Instrumentation Laboratory CO and Lin-Zhi International, Inc..

7
Total
7
Cleared
104d
Avg days
1983
Since

FDA 510(k) Cleared Coating, Liquid, Glc Devices (Product Code DLG)

7 devices
1–7 of 7
Cleared Apr 06, 2006
OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K050988
Lin-Zhi International, Inc.
Toxicology · 352d
Cleared Mar 11, 1992
IL TEST DAT CAL/CONTROL SET D/E
K920419
Instrumentation Laboratory CO
Toxicology · 40d
Cleared Sep 28, 1989
FPR AMIKACIN CALIBRATOR KIT
K894518
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 28, 1989
FPR GENTAMICIN CALIBRATOR KIT
K894524
Colony Laboratories, Inc.
Toxicology · 70d
Cleared Sep 25, 1989
FPR PHENYTOIN CALIBRATOR KIT
K894528
Colony Laboratories, Inc.
Toxicology · 67d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Dec 16, 1983
N-ACETYLPROCAINAMIDE CALIBRATOR
K833385
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 78d

About Product Code DLG - Regulatory Context