K103532 is an FDA 510(k) clearance for the AUTOREADER 2. This device is classified as a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II - Special Controls, product code LRG).
Submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on August 26, 2011, 268 days after receiving the submission on December 1, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K103532 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2010 |
| Decision Date | August 26, 2011 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |