The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Lyfo-disk Microorganisms.
Device ID | K842129 |
510k Number | K842129 |
Device Name: | LYFO-DISK MICROORGANISMS |
Classification | Kit, Quality Control For Culture Media |
Applicant | MICRO-BIO-LOGICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTR |
CFR Regulation Number | 866.2480 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-29 |
Decision Date | 1984-07-03 |