The following data is part of a premarket notification filed by Alamar Biosciences Laboratory, Inc. with the FDA for Readar.
| Device ID | K925951 |
| 510k Number | K925951 |
| Device Name: | READAR |
| 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 Lancaster |
| Correspondent | Michael Lancaster 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 | 1992-11-24 |
| Decision Date | 1993-08-31 |