The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrachem Gluc-dh.
Device ID | K821867 |
510k Number | K821867 |
Device Name: | ULTRACHEM GLUC-DH |
Classification | Glucose Dehydrogenase, Glucose |
Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LFR |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-25 |
Decision Date | 1982-07-06 |