K090563 is an FDA 510(k) clearance for the HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE). This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Instrumentation Laboratory CO (Orangeburg, US). The FDA issued a Cleared decision on October 9, 2009, 221 days after receiving the submission on March 2, 2009.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K090563 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2009 |
| Decision Date | October 09, 2009 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |