The following data is part of a premarket notification filed by Diagnostic Chemicals Ltd. with the FDA for Direct Bilirubin (dnd) Assay, Catalogue Number 209-05.
| Device ID | K955880 |
| 510k Number | K955880 |
| Device Name: | DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05 |
| Classification | Diazo Colorimetry, Bilirubin |
| Applicant | DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS LTD. WEST ROYALTY INDUSTRIAL PARK, Charlottetown, P.e.i., CA C1e 2a6 |
| Product Code | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-28 |
| Decision Date | 1996-08-27 |