The following data is part of a premarket notification filed by Em Diagnostic Systems, Inc. with the FDA for Systemate Amylase (amyl) Item Number 65404.
| Device ID | K903332 |
| 510k Number | K903332 |
| Device Name: | SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 |
| Classification | Catalytic Methods, Amylase |
| Applicant | EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Contact | Anna G Bentley |
| Correspondent | Anna G Bentley EM DIAGNOSTIC SYSTEMS, INC. 480 DEMOCRAT RD. Gibbstown, NJ 08027 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-08-17 |