The following data is part of a premarket notification filed by Monitor Science Corp. with the FDA for Bio-monitor Amikacin.
Device ID | K780949 |
510k Number | K780949 |
Device Name: | BIO-MONITOR AMIKACIN |
Classification | Amikacin Serum Assay |
Applicant | MONITOR SCIENCE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KLP |
CFR Regulation Number | 862.3035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-06-09 |
Decision Date | 1978-08-14 |