K081013 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN. 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 (West Sacramento, US). The FDA issued a Cleared decision on September 8, 2008, 152 days after receiving the submission on April 9, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K081013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2008 |
| Decision Date | September 08, 2008 |
| Days to Decision | 152 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 |