The following data is part of a premarket notification filed by Starplex Scientific, Inc. with the FDA for Multitrans Culture Collection And Transport System.
Device ID | K962843 |
510k Number | K962843 |
Device Name: | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM |
Classification | Culture Media, Non-propagating Transport |
Applicant | STARPLEX SCIENTIFIC, INC. 50-B STEINWAY BLVD. Etobicoke, Ontario, CA M9w 6y3 |
Contact | Mehdi Karamchi |
Correspondent | Mehdi Karamchi STARPLEX SCIENTIFIC, INC. 50-B STEINWAY BLVD. Etobicoke, Ontario, CA M9w 6y3 |
Product Code | JSM |
CFR Regulation Number | 866.2390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-22 |
Decision Date | 1996-09-18 |