K926248 is an FDA 510(k) clearance for the READER. This device is classified as a Instrument For Auto Reader Of Overnight Microorganism Identification System (Class I - General Controls, product code LRH).
Submitted by Alamar Biosciences Laboratory, Inc. (Sacramento, US). The FDA issued a Cleared decision on May 17, 1994, 519 days after receiving the submission on December 14, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K926248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1992 |
| Decision Date | May 17, 1994 |
| Days to Decision | 519 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LRH — Instrument For Auto Reader Of Overnight Microorganism Identification System |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |