The following data is part of a premarket notification filed by Sierra Diagnostic, L.l.c. with the FDA for Urine Collection, Preservation And Transport System.
| Device ID | K013819 |
| 510k Number | K013819 |
| Device Name: | URINE COLLECTION, PRESERVATION AND TRANSPORT SYSTEM |
| Classification | System, Transport, Aerobic |
| Applicant | SIERRA DIAGNOSTIC, L.L.C. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington, DC 20036 -1221 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone SIERRA DIAGNOSTIC, L.L.C. 1800 MASSACHUSETTS AVE., NW SUITE 200 Washington, DC 20036 -1221 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-16 |
| Decision Date | 2002-02-28 |
| Summary: | summary |