The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Amikacin Fluorescent Immunoassay.
Device ID | K813541 |
510k Number | K813541 |
Device Name: | AMIKACIN FLUORESCENT IMMUNOASSAY |
Classification | Radioimmunoassay, Amikacin |
Applicant | AMERICAN DIAGNOSTIC CORP. 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 | 1981-12-21 |
Decision Date | 1982-01-12 |