The following data is part of a premarket notification filed by Tech Intl. Co. with the FDA for Amylase (kinetic) Reagent Set.
| Device ID | K915704 |
| 510k Number | K915704 |
| Device Name: | AMYLASE (KINETIC) REAGENT SET |
| Classification | Nitrosalicylate Reduction, Amylase |
| Applicant | TECH INTL. CO. 911 VIA RODEO Placentia, CA 92670 |
| Contact | Chen |
| Correspondent | Chen TECH INTL. CO. 911 VIA RODEO Placentia, CA 92670 |
| Product Code | CJD |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-27 |
| Decision Date | 1996-06-28 |