FDA 510(k) Applications for Medical Device Product Code "PJD"

FDA 510(k) Number Applicant Device Name Decision Date
K970357 EPITOPE, INC. EPISCREEN 03/10/1997
K973395 EPITOPE, INC. EPISCREEN ORAL SPECIMEN COLLECTION DEVICE 02/13/1998
K183048 Immunalysis Corporation Quantisal II Oral Fluid Collection Device 07/29/2019
K200801 Immunalysis Corporation Quantisal Oral Fluid Collection Device 07/28/2020
K223781 Immunalysis Corporation QuantisalÖ II Oral Fluid Collection Device 07/28/2023
K011057 ORASURE TECHNOLOGIES, INC. INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX 06/06/2001
K984361 OSBORN LABORATORIES, INC. ORAL-EZE ORAL FLUID COLLECTION SYSTEM 01/13/1999


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