The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Salicylate Assay Kit, Catalogue Number 501-71.
| Device ID | K870336 |
| 510k Number | K870336 |
| Device Name: | SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71 |
| Classification | Colorimetry, Salicylate |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Contact | Callbeck, R.t. |
| Correspondent | Callbeck, R.t. DIAGNOSTIC CHEMICALS, LTD. (USA) 16 FIRST ST. WEST ROYALTY INDUSTRIAL PARK Charlottestown,pei,canada, CA C1e 1b0 |
| Product Code | DKJ |
| CFR Regulation Number | 862.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-02-20 |