The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Antimicrobial Gentamicin.
| Device ID | K911305 |
| 510k Number | K911305 |
| Device Name: | ANTIMICROBIAL GENTAMICIN |
| 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 | 1991-03-25 |
| Decision Date | 1991-04-22 |