The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Hdl Cholesterol Reagent.
Device ID | K872575 |
510k Number | K872575 |
Device Name: | HDL CHOLESTEROL REAGENT |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Contact | Mathew Madappally |
Correspondent | Mathew Madappally SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-30 |
Decision Date | 1987-07-16 |