The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Martin-lester Transgrow W/trimethoprin.
Device ID | K760692 |
510k Number | K760692 |
Device Name: | MARTIN-LESTER TRANSGROW W/TRIMETHOPRIN |
Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTY |
CFR Regulation Number | 866.2410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-21 |
Decision Date | 1976-10-07 |