FDA 510(k) Applications for Medical Device Product Code "DNK"
(Thin Layer Chromatography, Morphine)

FDA 510(k) Number Applicant Device Name Decision Date
K150602 GUANGZHOU WONDFO BIOTECH CO., LTD. CR3 Keyless Split Sample Cup Morphine - Methamphetamine 04/07/2015
K853140 MEDICAL DIAGNOSTICS, CA. MDI QUIK TEST NARCOTICS DRUG SCREEN 03/03/1986
K151557 NANTONG EGENS BIOTECH CO., LTD. EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine 07/16/2015
K970579 TECO DIAGNOSTICS ONE STEP MORPHINE CARD TEST 07/03/1997


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