The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Bilirubin Assay Kit (direct), Cata. Number 202-02.
| Device ID | K861094 |
| 510k Number | K861094 |
| Device Name: | BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02 |
| Classification | Diazo Colorimetry, Bilirubin |
| 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 | CIG |
| CFR Regulation Number | 862.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-24 |
| Decision Date | 1986-04-21 |