The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Viral Transport Med. (46-995-04).
Device ID | K802303 |
510k Number | K802303 |
Device Name: | VIRAL TRANSPORT MED. (46-995-04) |
Classification | Culture Media, Non-propagating Transport |
Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-23 |
Decision Date | 1980-10-31 |