Product code PJD

Device name: Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
Medical specialty: Clinical Chemistry
Device class: 2
Regulation number: 862.1675
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
Definition: Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K232898	Quantisal™ Oral Fluid Collection Device	Immunalysis Corporation	2023-11-21
K223781	Quantisal™ II Oral Fluid Collection Device	Immunalysis Corporation	2023-07-28
K200801	Quantisal Oral Fluid Collection Device	Immunalysis Corporation	2020-07-28
K183048	Quantisal II Oral Fluid Collection Device	Immunalysis Corporation	2019-07-29
K011057	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX	OraSure Technologies, Inc.	2001-06-06
K984361	ORAL-EZE ORAL FLUID COLLECTION SYSTEM	Osborn Laboratories, Inc.	1999-01-13
K973395	EPISCREEN ORAL SPECIMEN COLLECTION DEVICE	Epitope, Inc.	1998-02-13
K970357	EPISCREEN	Epitope, Inc.	1997-03-10
K942435	SALIVA SAMPLER	Saliva Diagnostic Systems, Inc.	1995-08-21

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840937113912	Immunalysis	IMMUNALYSIS CORP	2023-03-29
00840937113929	Immunalysis	IMMUNALYSIS CORP	2023-03-29
00840937113936	Immunalysis	IMMUNALYSIS CORP	2023-03-29
00840937103142	Immunalysis	IMMUNALYSIS CORPORATION	2023-03-29
00840937112069	Quantisal	IMMUNALYSIS CORPORATION	2020-10-06
00840937112052	Quantisal	IMMUNALYSIS CORPORATION	2020-10-06
00840937112168	Quantisal	IMMUNALYSIS CORPORATION	2020-08-31
00840937112151	Quantisal	IMMUNALYSIS CORPORATION	2020-08-31
00840937112144	Immunalysis	IMMUNALYSIS CORP	2020-08-31
20608337000119	OraSure Oral Fluid Collection Device	Orasure Technologies, Inc.	2019-02-15
00608337000115	OraSure Oral Fluid Collection Device	Orasure Technologies, Inc.	2019-02-15
10859952006236	Oral-Eze	CAPITOL VIAL, INC.	2018-08-31
30859952006261	Oral-Eze	CAPITOL VIAL, INC.	2018-08-31
00840937110812	Immunalysis	IMMUNALYSIS CORP	2018-04-20
00840937110829	Immunalysis	IMMUNALYSIS CORP	2018-04-20
10859952006045	Oral-Eze	CAPITOL VIAL, INC.	2018-01-12
00859952006093	Oral-Eze	CAPITOL VIAL, INC.	2017-07-25
00859952006109	Oral-Eze	CAPITOL VIAL, INC.	2017-07-25
00859952006086	Oral-Eze	CAPITOL VIAL, INC.	2017-04-27
00859952006079	Oral-Eze	CAPITOL VIAL, INC.	2017-04-27
00859952006062	Oral-Eze	CAPITOL VIAL, INC.	2017-04-27
00859952006055	Oral-Eze	CAPITOL VIAL, INC.	2017-04-27
00884883012585	Oral-Eze Collection System	Microgenics Corporation	2016-09-12
00859952006031	Oral-Eze	CAPITOL VIAL, INC.	2016-09-10
00859952006024	Oral-Eze	CAPITOL VIAL, INC.	2016-09-10
00859952006017	Oral-Eze	CAPITOL VIAL, INC.	2016-09-10
00859952006000	Oral-Eze	CAPITOL VIAL, INC.	2016-09-10
00840937105108	Immunalysis	IMMUNALYSIS CORP	2016-08-31
00840937105078	Immunalysis	IMMUNALYSIS CORP	2016-08-31
00608337000078	Intercept	Orasure Technologies, Inc.	2016-07-29

Product code PJD

Related 510(k) Records#

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