Episcreen
FDA 510(k) K970357 · Epitope, Inc.
510(k) numberK970357
Submission
- Device name
- Episcreen
- Applicant
- Epitope, Inc.
Beaverton, OR, US - Received
- January 30, 1997
- Decision date
- March 10, 1997
- 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 |
| K984361 | Oral-Eze Oral Fluid Collection SystemPJD · Traditional | Osborn Laboratories, Inc. | 01/13/1999SE |
| K973395 | Episcreen Oral Specimen Collection DevicePJD · Traditional | Epitope, Inc. | 02/13/1998SE |
| K942435 | Saliva SamplerPJD · Traditional | Saliva Diagnostic Systems, Inc. | 08/21/1995SE |
More from Saliva Diagnostic Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973395 | Episcreen Oral Specimen Collection DevicePJD · Traditional | 02/13/1998SE |
Questions and answers
When was Episcreen cleared by the FDA?
Episcreen (K970357) received a 510(k) decision of Substantially Equivalent on March 10, 1997, 39 days after the submission was received.
What is the product code of K970357?
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.