The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Salicylate Assay (ace), Catalogue Number 501-71.
| Device ID | K980032 |
| 510k Number | K980032 |
| Device Name: | SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 |
| Classification | Colorimetry, Salicylate |
| 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 | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-05 |
| Decision Date | 1998-03-02 |