The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cell-matics Viral Transport Pack.
Device ID | K843173 |
510k Number | K843173 |
Device Name: | CELL-MATICS VIRAL TRANSPORT PACK |
Classification | System, Transport, Aerobic |
Applicant | DIFCO LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTW |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-13 |
Decision Date | 1984-09-06 |