FDA 510(k) Applications for Medical Device Product Code "DLG"
(Coating, Liquid, Glc)

FDA 510(k) Number Applicant Device Name Decision Date
K894518 COLONY LABORATORIES, INC. FPR AMIKACIN CALIBRATOR KIT 09/28/1989
K894524 COLONY LABORATORIES, INC. FPR GENTAMICIN CALIBRATOR KIT 09/28/1989
K894528 COLONY LABORATORIES, INC. FPR PHENYTOIN CALIBRATOR KIT 09/25/1989
K833385 E.I. DUPONT DE NEMOURS & CO., INC. N-ACETYLPROCAINAMIDE CALIBRATOR 12/16/1983
K882766 EM DIAGNOSTIC SYSTEMS, INC. EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 08/23/1988
K920419 INSTRUMENTATION LABORATORY CO. IL TEST DAT CAL/CONTROL SET D/E 03/11/1992
K050988 Lin-Zhi International, Inc. OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS 04/06/2006


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