The following data is part of a premarket notification filed by Orasure Technologies, Inc. with the FDA for Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-xxxx.
| Device ID | K011057 |
| 510k Number | K011057 |
| Device Name: | INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX |
| Classification | Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device |
| Applicant | ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Contact | R.sam Niedbala |
| Correspondent | R.sam Niedbala ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. Bethelehem, PA 18015 -1389 |
| Product Code | PJD |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-06 |
| Decision Date | 2001-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60608337000070 | K011057 | 000 |