K100716 is an FDA 510(k) clearance for the AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5. This device is classified as a Plasma, Coagulation Control (Class II - Special Controls, product code GGN).
Submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on June 23, 2011, 468 days after receiving the submission on March 12, 2010.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K100716 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2010 |
| Decision Date | June 23, 2011 |
| Days to Decision | 468 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 |