510(k) K011057
- Device
- INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
- Applicant
- ORASURE TECHNOLOGIES, INC.
- 510(k) number
- K011057
- Product code
- PJD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-06
- Date received
- 2001-04-06
- Regulation
- 862.1675
- Classification name
- Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- R.SAM NIEDBALA
- Address
- 150 Webster St. Bethlehem PA US 18015 18015
FDA Registration Numbers#
- 2020952
- 2029372
- 3010939897
- 3011945100
- 3008264082
Source Documents#
Other 510(k) Records For Product Code PJD #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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