The following data is part of a premarket notification filed by Micro-media Systems, Inc. with the FDA for Test Panel For Presump. Id/bact. Org.
Device ID | K801547 |
510k Number | K801547 |
Device Name: | TEST PANEL FOR PRESUMP. ID/BACT. ORG |
Classification | Kit, Anaerobic Identification |
Applicant | MICRO-MEDIA SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSP |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-07-07 |
Decision Date | 1980-09-09 |