Oral-Eze Oral Fluid Collection System
FDA 510(k) K984361 · Osborn Laboratories, Inc.
510(k) numberK984361
Submission
- Device name
- Oral-Eze Oral Fluid Collection System
- Applicant
- Osborn Laboratories, Inc.
Olathe, KS, US - Received
- December 7, 1998
- Decision date
- January 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PJD – Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Intended for use in the collection, preservation, and transport of oral fluid specimens for drugs of abuse or alcohol testing.
Other 510(k)s with product code PJD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232898 | Quantisal Oral Fluid Collection DevicePJD · Traditional | Immunalysis Corporation | 11/21/2023SE |
| K223781 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | Immunalysis Corporation | 07/28/2023SE |
| K200801 | Quantisal Oral Fluid Collection DevicePJD · Traditional | Immunalysis Corporation | 07/28/2020SE |
| K183048 | Quantisal II Oral Fluid Collection DevicePJD · Traditional | Immunalysis Corporation | 07/29/2019SE |
| K011057 | Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXXPJD · Traditional | OraSure Technologies, Inc. | 06/06/2001SE |
| K973395 | Episcreen Oral Specimen Collection DevicePJD · Traditional | Epitope, Inc. | 02/13/1998SE |
| K970357 | EpiscreenPJD · Traditional | Epitope, Inc. | 03/10/1997SE |
| K942435 | Saliva SamplerPJD · Traditional | Saliva Diagnostic Systems, Inc. | 08/21/1995SE |
More from Saliva Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984529 | Hemochek Sample Collection KitLCP · Traditional | 01/28/1999SE |
Questions and answers
When was Oral-Eze Oral Fluid Collection System cleared by the FDA?
Oral-Eze Oral Fluid Collection System (K984361) received a 510(k) decision of Substantially Equivalent on January 13, 1999, 37 days after the submission was received.
What is the product code of K984361?
The FDA product code is PJD – Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device, a Class II (moderate risk) device regulated under 21 CFR 862.1675.