The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Catalogue Number 321-07/15/50.
| Device ID | K945243 |
| 510k Number | K945243 |
| Device Name: | CATALOGUE NUMBER 321-07/15/50 |
| Classification | Catalytic Methods, Amylase |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-27 |
| Decision Date | 1995-02-08 |