The following data is part of a premarket notification filed by American Dade with the FDA for Stratus Amikacin Fluorometric.
Device ID | K832336 |
510k Number | K832336 |
Device Name: | STRATUS AMIKACIN FLUOROMETRIC |
Classification | Radioimmunoassay, Amikacin |
Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLQ |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-08-31 |