The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Amylase Liquid Reagent, Model A532-200.
| Device ID | K040920 |
| 510k Number | K040920 |
| Device Name: | AMYLASE LIQUID REAGENT, MODEL A532-200 |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2004-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001136 | K040920 | 000 |
| 10673486001129 | K040920 | 000 |