The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Amy Reagent.
| Device ID | K852001 |
| 510k Number | K852001 |
| Device Name: | AMY REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | Yosip F Warda |
| Correspondent | Yosip F Warda ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-06-10 |