The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for General Diagnostics Ticarcillin 75mcg Suscept-disk.
Device ID | K850957 |
510k Number | K850957 |
Device Name: | GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK |
Classification | Susceptibility Test Discs, Antimicrobial |
Applicant | WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
Contact | Lynn Decaro |
Correspondent | Lynn Decaro WARNER-LAMBERT CO. 201 TABOR RD. Morris Plains, NJ 07950 |
Product Code | JTN |
CFR Regulation Number | 866.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-08 |
Decision Date | 1985-05-01 |