The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Alamar Bacterial Identification Test Panel.
| Device ID | K926002 |
| 510k Number | K926002 |
| Device Name: | ALAMAR BACTERIAL IDENTIFICATION TEST PANEL |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | ALAMAR BIOSCIENCES LABORATORY, INC. 4110 N. FREEWAY BLVD. Sacramento, CA 95834 -1219 |
| Contact | Michael V Lancaster |
| Correspondent | Michael V Lancaster ALAMAR BIOSCIENCES LABORATORY, INC. 4110 N. FREEWAY BLVD. Sacramento, CA 95834 -1219 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-27 |
| Decision Date | 1993-09-23 |