The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Amylase Reagent.
| Device ID | K896650 |
| 510k Number | K896650 |
| Device Name: | AMYLASE REAGENT |
| Classification | Catalytic Methods, Amylase |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-24 |
| Decision Date | 1990-02-08 |