The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Amylase Reagent Set (kinetic).
| Device ID | K931080 |
| 510k Number | K931080 |
| Device Name: | AMYLASE REAGENT SET (KINETIC) |
| Classification | Catalytic Methods, Amylase |
| Applicant | TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Contact | Chen |
| Correspondent | Chen TECO DIAGNOSTICS 911 VIA RODEO Placentia, CA 92670 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-02 |
| Decision Date | 1993-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001143 | K931080 | 000 |