The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urs-1b (blood Test).
| Device ID | K023297 |
| 510k Number | K023297 |
| Device Name: | URS-1B (BLOOD TEST) |
| Classification | Blood, Occult, Colorimetric, In Urine |
| Applicant | TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Lisa To |
| Correspondent | Lisa To TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JIO |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-02 |
| Decision Date | 2003-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00664816000076 | K023297 | 000 |
| 10673486000146 | K023297 | 000 |
| 10673486000139 | K023297 | 000 |
| 10673486000122 | K023297 | 000 |
| 10673486000085 | K023297 | 000 |