The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Salicylate Assay Kit.
| Device ID | K842158 |
| 510k Number | K842158 |
| Device Name: | SALICYLATE ASSAY KIT |
| Classification | Colorimetry, Salicylate |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Contact | Karen Mcmahon |
| Correspondent | Karen Mcmahon DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-10-22 |