The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Albumin Assay Kit.
| Device ID | K843104 |
| 510k Number | K843104 |
| Device Name: | ALBUMIN ASSAY KIT |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-07 |
| Decision Date | 1984-09-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628063400072 | K843104 | 000 |
| 00628063400065 | K843104 | 000 |
| 00628063400058 | K843104 | 000 |