The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Diagnostics Uti Detection Strips.
| Device ID | K100024 |
| 510k Number | K100024 |
| Device Name: | TECO DIAGNOSTICS UTI DETECTION STRIPS |
| Classification | Diazo (colorimetric), Nitrite (urinary, Non-quant) |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Kc Chen |
| Correspondent | Kc Chen TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JMT |
| CFR Regulation Number | 862.1510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-05 |
| Decision Date | 2011-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486000412 | K100024 | 000 |