The following data is part of a premarket notification filed by Skoug Research Corp. with the FDA for Bionor Transportmedium.
Device ID | K925450 |
510k Number | K925450 |
Device Name: | BIONOR TRANSPORTMEDIUM |
Classification | Culture Media, Anaerobic Transport |
Applicant | SKOUG RESEARCH CORP. PO BOX 405 Cambridge, MA 02141 |
Contact | Erik Skoug |
Correspondent | Erik Skoug SKOUG RESEARCH CORP. PO BOX 405 Cambridge, MA 02141 |
Product Code | JSL |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-28 |
Decision Date | 1993-06-25 |