The following data is part of a premarket notification filed by Emd Chemicals Inc. with the FDA for Ultrachem Enzymatic Chol. Oxidase.
Device ID | K822418 |
510k Number | K822418 |
Device Name: | ULTRACHEM ENZYMATIC CHOL. OXIDASE |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | EMD CHEMICALS INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-11 |
Decision Date | 1982-09-14 |