The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urs-1k (ketone Tesst).
| Device ID | K003987 |
| 510k Number | K003987 |
| Device Name: | URS-1K (KETONE TESST) |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Contact | Dindo Carrillo |
| Correspondent | Dindo Carrillo TECO DIAGNOSTICS 4925 EAST HUNTER AVE. Anaheim, CA 92807 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-26 |
| Decision Date | 2001-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00664816000014 | K003987 | 000 |
| 10673486000597 | K003987 | 000 |
| 10673486000474 | K003987 | 000 |
| 10673486000207 | K003987 | 000 |
| 10673486000191 | K003987 | 000 |
| 10673486000184 | K003987 | 000 |