The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Cholesterol Asssay Kit.
Device ID | K842160 |
510k Number | K842160 |
Device Name: | CHOLESTEROL ASSSAY KIT |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4 NEWLAND CRESCENT CHARLOTTETOWN Canada, |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-30 |
Decision Date | 1984-08-17 |