The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Alamar Antibiotic Susceptibility.
| Device ID | K941425 |
| 510k Number | K941425 |
| Device Name: | ALAMAR ANTIBIOTIC SUSCEPTIBILITY |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | ALAMAR BIOSCIENCES LABORATORY, INC. 4110 N. FREEWAY BLVD. Sacramento, CA 95834 -1219 |
| Contact | Michael V Lancaster, Ph.d |
| Correspondent | Michael V Lancaster, Ph.d ALAMAR BIOSCIENCES LABORATORY, INC. 4110 N. FREEWAY BLVD. Sacramento, CA 95834 -1219 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-23 |
| Decision Date | 1994-12-15 |