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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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