The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Bilirubin Assay Kit Direct.
Device ID | K843027 |
510k Number | K843027 |
Device Name: | BILIRUBIN ASSAY KIT DIRECT |
Classification | Diazo Colorimetry, Bilirubin |
Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
Product Code | CIG |
CFR Regulation Number | 862.1110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-01 |
Decision Date | 1984-09-04 |