The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Creatinine Assay Kit.
| Device ID | K843377 |
| 510k Number | K843377 |
| Device Name: | CREATININE ASSAY KIT |
| Classification | Alkaline Picrate, Colorimetry, Creatinine |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | CGX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-28 |
| Decision Date | 1984-09-28 |