The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Total Protein Assay Kit.
| Device ID | K843028 |
| 510k Number | K843028 |
| Device Name: | TOTAL PROTEIN ASSAY KIT |
| Classification | Biuret (colorimetric), Total Protein |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | CEK |
| CFR Regulation Number | 862.1635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-01 |
| Decision Date | 1984-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400881 | K843028 | 000 |
| 00628063400874 | K843028 | 000 |