The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Antimicrobial Suscept. Test Panel Ticarcillin.
Device ID | K911557 |
510k Number | K911557 |
Device Name: | ANTIMICROBIAL SUSCEPT. TEST PANEL TICARCILLIN |
Classification | Manual Antimicrobial Susceptibility Test Systems |
Applicant | ALAMAR BIOSCIENCES LABORATORY, INC. 3401 LA GRANDE BLVD. Sacramento, CA 95823 |
Contact | Michael V Lancaster |
Correspondent | Michael V Lancaster ALAMAR BIOSCIENCES LABORATORY, INC. 3401 LA GRANDE BLVD. Sacramento, CA 95823 |
Product Code | JWY |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-08 |
Decision Date | 1991-04-22 |