Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX
FDA 510(k) K011057 · OraSure Technologies, Inc.
510(k) numberK011057
Submission
- Device name
- Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX
- Applicant
- OraSure Technologies, Inc.
Bethlehem, PA, US - Received
- April 6, 2001
- Decision date
- June 6, 2001
- 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.
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| K942435 | Saliva SamplerPJD · Traditional | Saliva Diagnostic Systems, Inc. | 08/21/1995SE |
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Questions and answers
When was Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX cleared by the FDA?
Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX (K011057) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 61 days after the submission was received.
What is the product code of K011057?
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.