The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Teco Microalbumin 2-1 Combo Strips.
| Device ID | K061419 |
| 510k Number | K061419 |
| Device Name: | TECO MICROALBUMIN 2-1 COMBO STRIPS |
| Classification | Indicator Method, Protein Or Albumin (urinary, Non-quant.) |
| Applicant | TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Contact | Jian Vaeches |
| Correspondent | Jian Vaeches TECO DIAGNOSTICS 1268 NORTH LAKEVIEW AVE. Anaheim, CA 92807 |
| Product Code | JIR |
| CFR Regulation Number | 862.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-22 |
| Decision Date | 2007-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066003640 | K061419 | 000 |
| 10673486000573 | K061419 | 000 |
| 10673486000252 | K061419 | 000 |
| 10673486000245 | K061419 | 000 |