The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Amylase-sl Assay Catalogue Number 341-10.
| Device ID | K974053 |
| 510k Number | K974053 |
| Device Name: | AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 |
| Classification | Catalytic Methods, Amylase |
| Applicant | DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottetown, P.e.i., CA C1e1b0 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-27 |
| Decision Date | 1997-12-08 |