K111677 is an FDA 510(k) clearance for the MICROSCAN(R) MICROSTREP PLUS(R). This device is classified as a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II - Special Controls, product code LRG).
Submitted by Siemens Healthcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on August 4, 2011, 50 days after receiving the submission on June 15, 2011.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K111677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2011 |
| Decision Date | August 04, 2011 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |