The following data is part of a premarket notification filed by Monitor Science Corp. with the FDA for Kanamycin Ria.
Device ID | K772038 |
510k Number | K772038 |
Device Name: | KANAMYCIN RIA |
Classification | Radioimmunoassay, Kanamycin |
Applicant | MONITOR SCIENCE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KJI |
CFR Regulation Number | 862.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-10-28 |
Decision Date | 1978-01-12 |