The following data is part of a premarket notification filed by Biological Corp. Of America with the FDA for Em-x.
Device ID | K812222 |
510k Number | K812222 |
Device Name: | EM-X |
Classification | Media, Potentiating For In Vitro Diagnostic Use |
Applicant | BIOLOGICAL CORP. OF AMERICA 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSG |
CFR Regulation Number | 864.9600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-08-07 |
Decision Date | 1981-09-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EM-X 76037104 2549123 Live/Registered |
EM Research Organization, Inc. 2000-04-28 |