K221508 is an FDA 510(k) clearance for the AnemoCheck Home. This device is classified as a Whole Blood Hemoglobin Determination (Class II - Special Controls, product code KHG).
Submitted by Sanguina, Inc. (Peachtree Corners, US). The FDA issued a Cleared decision on September 29, 2023, 493 days after receiving the submission on May 24, 2022.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7500.
| 510(k) Number | K221508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 24, 2022 |
| Decision Date | September 29, 2023 |
| Days to Decision | 493 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KHG - Whole Blood Hemoglobin Determination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7500 |