The following data is part of a premarket notification filed by American Dade with the FDA for Paramax Ammonia Reagentt.
Device ID | K840770 |
510k Number | K840770 |
Device Name: | PARAMAX AMMONIA REAGENTT |
Classification | Enzymatic Method, Ammonia |
Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIF |
CFR Regulation Number | 862.1065 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-28 |
Decision Date | 1984-04-04 |