The following data is part of a premarket notification filed by Streck with the FDA for Ua-cellular Complete.
| Device ID | K131444 |
| 510k Number | K131444 |
| Device Name: | UA-CELLULAR COMPLETE |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Contact | Deborah Kipp |
| Correspondent | Deborah Kipp Streck 7002 SOUTH 109TH ST. Omaha, NE 68128 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2014-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509001935 | K131444 | 000 |