The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Cultureswab Transport System.
Device ID | K934894 |
510k Number | K934894 |
Device Name: | CULTURESWAB TRANSPORT SYSTEM |
Classification | System, Transport, Aerobic |
Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
Contact | David W Gates |
Correspondent | David W Gates DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
Product Code | JTW |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-05 |
Decision Date | 1994-02-22 |