K192842 is an FDA 510(k) clearance for the HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High. This device is classified as a Control, Hemoglobin (Class II - Special Controls, product code GGM).
Submitted by Eurotrol B.V. (Ede, NL). The FDA issued a Cleared decision on November 15, 2019, 43 days after receiving the submission on October 3, 2019.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K192842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGM - Control, Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |