The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrazyme Plus Amyl.
Device ID | K821869 |
510k Number | K821869 |
Device Name: | ULTRAZYME PLUS AMYL |
Classification | Catalytic Methods, Amylase |
Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JFJ |
CFR Regulation Number | 862.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-25 |
Decision Date | 1982-07-13 |